FDA Approved Drugs: January 2020

The Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.
FDA Update

Ogivri, a Herceptin Biosimilar, Launched

Two years after its FDA approval, Ogivri (trastuzumab-dkst) was introduced in the U.S. on Dec. 2, 2019. Co-developed by Mylan and Biocon Biologics, the biosimilar for Genentech’s Herceptin® (trastuzumab) is used to treat breast cancers and metastatic stomach cancers (gastric or gastroesophageal junction adenocarcinomas) that overexpress the HER2 gene (HER2+). It is given as an intravenous (IV) infusion at varying loading/maintenance doses and on schedules that also vary according to the cancer being treated. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. Ogivri will compete not only with Herceptin, but also with Kanjinti (trastuzumab-anns), a biosimilar from Amgen and Allergan that was marketed in the U.S. on July 18, 2019, and with other FDA-approved biosimilars that have not yet been released for sale. However, Ogivri is not interchangeable with Herceptin, Kanjinti or any other Herceptin biosimilar. Although exact pricing is not yet known, Mylan intends to distribute Ogivri at a “competitive discount” to Herceptin. For its prescribing information, look here.

Expanded Indication for Tecentriq

The FDA approved a new indication for Tecentriq® (atezolizumab - Genentech) on Dec. 4, 2019, as initial therapy for previously untreated adults who have metastatic non-squamous non-small cell lung cancer (NSCLC) that does not have genomic aberrations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK). It will be used along with two chemotherapy (chemo) drugs, carboplatin and Abraxane® (paclitaxel protein-bound particles for injectable suspension – Abraxis BioScience). For the new indication, Tecentriq is infused IV once every three weeks at a dose of 1200mg. If it is administered on the same day as chemo, it should be given first. Following four to six chemo cycles, dosing for Tecentriq may be adjusted to once every two, three or four weeks at differing doses. It should be used as long as the cancer does not spread or the patient is unable to tolerate further treatment. Here is updated prescribing information for Tecentriq.

Avsola, a Biosimilar to Remicade, Receives FDA Approval

Avsola (infliximab-axxq - Amgen) gained FDA approval on Dec. 6, 2019. A biosimilar for Remicade® (infliximab – Janssen Biotech), it is an anti-tumor necrosis factor alpha (TNFα) monoclonal antibody for treating the inflammatory conditions ankylosing spondylitis, Crohn's disease (for both adults and children), plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) and ulcerative colitis (UC) – the same indications as Remicade. Administered by IV infusion, its doses and timing differ according to the condition being treated. As with all TNF drugs, the labeling for Avsola has a boxed warning that using it may increase the risk of serious bacterial or fungal infections that include tuberculosis (TB). Children and teens who use it may be more likely to have lymphoma or other cancers. It will compete with Remicade and two other biosimilars, Pfizer/Celltrion’s Inflectra® (infliximab-dyyb), which entered the U.S. market in November 2016, and Merck/Samsung Bioepis’ Renflexis (infliximab-abda), released in the United States on July 24, 2017. Another biosimilar, Pfizer’s Ixifi (infliximab-qbtx) is FDA approved, but it is not likely to be introduced in the United States. Amgen has not yet announced launch or pricing plans, but it expects to price Avsola competitively with the other available biosimilars, which wholesale for 20% to 30% less than Remicade. Prescribing information for Avsola is here.

Generics to Afinitor Launched

The first generics to Afinitor® (everolimus – Novartis) were approved on Dec. 9, 2019. Several manufacturers have announced the launch of generics to the 2.5mg, 5mg and 7.5mg tablets. An announcement regarding the launch of generics to the 10mg tablet strength is still pending, but they may be delayed until 2020. Afinitor, an mTOR inhibitor, was first approved in March 2009 for the second-line treatment of advanced renal cell carcinoma (RCC) after failure of treatment with Sutent® (sunitinib - Pfizer) or Nexavar® (sorafenib - Bayer). It has since been approved for several additional cancer types. Annual U.S. sales for Afinitor 2.5mg, 5mg and 7.5mg tablets are approximately $412 million, according to IQVIA.

Generic to NuvaRing Launched

On Dec. 12, 2019, the FDA approved Amneal’s EluRyng (etonogestrel/ethinyl estradiol vaginal ring). It’s the first A-rated generic to Merck’s hormonal contraceptive, NuvaRing®. The recommended dose is one ring self-inserted vaginally. The ring must remain in place continuously for three weeks, followed by a one-week ring-free interval. Amneal has already begun shipping. Pricing and prescribing information are not yet available. According to IQVIA, U.S. annual sales for NuvaRing are approximately $976 million. Other companies developing generics to NuvaRing include Teva, Mayne and Dr. Reddy’s. However, since NuvaRing is a complex dosage form, additional generic competition is not expected until 2020.

Vyondys 53 Approved for Duchenne Muscular Dystrophy

On Dec. 12, 2019, the FDA approved Sarepta Therapeutics’ Vyondys 53 (golodirsen) for the treatment of Duchenne muscular dystrophy (DMD) for patients with a confirmed mutation amenable to exon 53 skipping. DMD is a rare genetic disease that affects around 10,000 boys and young men in the United States. In DMD, a mutation in the gene for dystrophin, a muscle protein, causes progressive muscle wasting. Eventually, DMD patients need to use wheelchairs and ventilators. Currently, few patients live beyond 30 years of age. About 8% of patients with DMD have a confirmed mutation amenable to exon 53 skipping. Exons are bits of DNA or RNA that contain the information needed to produce specific proteins. Vyondys 53 is an antisense oligonucleotide that works by “skipping” over exon 53 to result in shorter, but partially functioning dystrophin. It is given as a once-weekly IV infusion at a dose of 30mg/kg of body weight. Sarepta launched Vyondys 53 immediately at a price in parity to Exondys 51® (eteplirsen – Sarepta Therapeutics). Exondys 51, also dosed based on a patient’s weight, costs more than $1 million per year for some patients. Full prescribing information for Vyondys 53 can be found here.

Ulcerative Colitis Indication for Xeljanz XR

Pfizer’s once-daily Xeljanz® XR (tofacitinib extended-release) was FDA approved on Dec. 13, 2019, to treat adult patients who have moderate-to-severe forms of ulcerative colitis (UC), after an inadequate response or intolerance to TNF blockers. UC is an inflammatory condition believed to affect about 900,000 Americans. Regular-release Xeljanz, which is generally administered twice daily, was granted approval to treat UC in May 2018. Xeljanz/XR, an oral Janus kinase (JAK) inhibitor, blocks JAK pathways that relay inflammatory signals within cells. It is also approved to treat PsA and RA. Its labeling includes a boxed warning about its potential risk of causing serious infections and cancers. Treatment with Xeljanz/XR may also increase cholesterol levels, increase liver enzymes and decrease blood counts. To inform healthcare providers and patients about the serious risks associated with Xeljanz/XR, it is dispensed under a risk evaluation and mitigation strategy (REMS) and with a Medication Guide. Updated prescribing information for Xeljanz/XR is here.

Vascepa Gains New Indication

A new indication was awarded on Dec. 13, 2019, for Vascepa® (icosapent ethyl - Amarin) capsules. In combination with the highest tolerated dose of a statin, Vascepa now is FDA approved to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization for adults who have triglyceride (TG) levels of 150 mg/dL or more plus established cardiovascular (CV) disease or who have diabetes mellitus along with two or more additional risk factors for CV disease. The recommended daily dose is four grams (as two doses each of either four 0.5gm capsules or two one gram capsules) swallowed whole along with food. Vascepa was originally approved in 2012 to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Patients should be cautioned that taking Vascepa may increase the risk of atrial fibrillation, atrial flutter and bleeding. Because it is derived from fish oils, Vascepa may cause allergic reactions for people who are allergic to fish or shellfish. Blood lipid levels should be checked regularly and patients should continue dietary modifications, exercise and statin therapy while taking Vascepa. Its updated prescribing information is here.

Generics Launching for Jadenu

In early and mid-December, several generic companies, including Alembic, Dr. Reddy’s Laboratories, Teva and Zydus, received FDA approval for AB-rated generics to Jadenu® (deferasirox - Novartis) tablets, 90mg and 360mg. Some launched immediately. A once-daily chelating agent, deferasirox is indicated for patients at least two years old who have transfusional hemosiderosis -- chronically high levels of iron that are caused by repeated blood transfusions. It also may be used to treat certain patients age 10 years and older who have chronic iron overload due to non-transfusion dependent thalassemia. Untreated chronic iron overload increases the chances of having arthritis, diabetes, heart problems, liver diseases and other conditions. However, deferasirox has a boxed warning that it may cause severe kidney, liver or stomach damage. Patients who use it should have kidney and liver function tests every month. Doses, which may be adjusted frequently, depend on the patient’s kidney function. Jadenu tablets, 180mg and Jadenu® Sprinkle (deferasirox) granules remain brand-only. IQVIA estimated that combined sales of 90mg and 360mg Jadenu tablets amounted to approximately $420 million in 2018.

New Xtandi Indication

Xtandi® (enzalutamide – Astellas/Pfizer) capsules received FDA approval on Dec. 16, 2019, for its third U.S. indication. Previously approved to treat both metastatic and non-metastatic castration-resistant prostate cancer, it now also is indicated for patients who have metastatic castration-sensitive prostate cancer. The new indication treats prostate cancers that have spread, but that still respond to an androgen deprivation therapy (ADT), either after surgery or with a drug such as Xoladex® (goserelin). In a clinical trial that included 1,150 patients, taking Xtandi along with ADT resulted in 61% fewer disease progressions or deaths among treated patients than among participants who used ADT and a placebo. Astellas projects that 40,000 additional patients may be eligible for treatment under the new indication. The recommended dose for Xtandi is 160mg (four capsules) taken together once a day. Check here for its complete prescribing information.

FDA Approves Padcev to Treat Urothelial Cancer

The FDA approved Padcev (enfortumab vedotin-ejfv) for injection on Dec.18, 2019. Jointly developed by Astellas and Seattle Genetics, it is the first drug to combine a drug with an antibody that targets Nectin-4, which is a protein expressed by urothelial (bladder) cancer cells. It is indicated for adult patients who have advanced or metastatic urothelial cancer that has already been treated with platinum-based chemo and a programmed cell death-1 (PD-1) inhibitor or a programmed death-ligand 1 (PD-L1) inhibitor. The antibody sticks to Nectin-4, and then the drug enters the cancer cells, releases the anti-tumor agent monomethyl auristatin E (MMAE) and stops cancer cells from replicating and/or surviving. Given as a 30-minute IV infusion, its recommended dosing is 1.25mg/kg on the first, eighth and fifteenth days of 28-day treatment cycles. Estimated wholesale acquisition cost (WAC) is $110,000 to $120,000 for a full course of treatment, depending on the patient’s weight and the duration of therapy. Padcev was launched soon after approval, but through hospitals and clinics, only. For its full prescribing information, look here.

FDA Approval of Arazlo for Acne

Ortho Dermatologics was granted FDA approval on Dec. 18, 2019, for a new acne treatment, Arazlo (tazarotene) lotion, 0.045%. It is indicated for patients at least nine years old. A retinoid, it will be applied lightly once a day to areas affected by acne. Patients should avoid getting it into the eyes and on mucous membranes. In clinical trials, patients using Arazlo, which contains moisturizers, reported less dryness and skin irritation than participants who used a 0.1% tazarotene cream. Both products showed comparable results for controlling acne. A launch is planned for the first half of 2020 at an undisclosed cost. It will be dispensed in 45Gm tubes. Prescribing information for Arazlo may be found here.

First Vaccine Approved for Ebola

On Dec. 19, 2019, the FDA approved Merck’s Ervebo® (Ebola Zaire vaccine, live), the first vaccine for the prevention of an Ebola virus disease. Indicated to protect individuals who are at least 18 years old from the Zaire strain of Ebola, it is not effective for other Ebola strains or for the similar Marburgvirus. Single doses of one mg will be injected intramuscularly (IM) into the upper arm. How long immunity takes to develop and how long it lasts are not entirely clear. Although Ebola is extremely rare in the United States, Merck and agencies of the U.S. have been working with the World Health Organization (WHO) and other groups to contain Ebola in other parts of the world. Commercial production of Ervebo will increase over the next several months, with full capacity expected in the third quarter of 2020. In the interim, Merck will continue to provide doses of the investigational vaccine to areas where Ebola outbreaks are occurring. Ervebo was FDA approved in less than six months as a Breakthrough Therapy, under Priority Review and with a Tropical Disease Priority Review Voucher. For prescribing information, look here.

Pediatric Indication Approved for Fiasp

Novo Nordisk’s rapid-acting insulin, Fiasp® (insulin aspart injection) was FDA approved on Dec. 19, 2019, for use by pediatric patients. First approved for U.S. adults in 2017, it is indicated to manage blood sugar levels for patients who have either type 1 or type 2 diabetes. Because it has been modified to increase absorption, the effects of Fiasp begin very soon after injection. Recommendations are to inject it right before a meal or within 20 minutes of beginning to eat. It is dispensed in 10mL multi-dose vials, pre-filled FlexTouch® pen devices and cartridges for use in a PenFill® device. Please go here for full prescribing information.

New Drug Approved to Treat Hypertension

On Dec. 19, 2019, the FDA approved Conjupri® (levamlodipine) tablets to treat hypertension. A third-generation calcium channel blocker, it is a derivative of amlodipine, the active ingredient in Pfizer’s Norvasc®, which also is available as generics. Indicated to treat high blood pressure for patients at least six years old, it may be used alone or along with other types of antihypertensives. It will be distributed in 1.25mg, 2.5mg and 5mg strengths. For very young patients, frail older patients and those who have liver conditions, the recommended starting dose is 1.25mg once daily, which may be raised, if needed, to 2.5mg/day for older pediatric patients. Most patients will start on a once-daily dose of 2.5mg, with a maximum of 5mg once a day. Check here for prescribing and patient information.

MedWatch Update

Gabapentin and Pregabalin

In a Safety Communication released on Dec. 19, 2019, the FDA reported possible breathing problems when gabapentin or pregabalin are taken along with other drugs that depress the central nervous system (CNS). Drugs for allergies, anxiety and depression may cause severe difficulties with breathing, as could opioids, if taken at the same time as gabapentin or pregabalin. Seniors and patients who already have breathing conditions, including chronic obstructive pulmonary disease (COPD), are particularly at risk. Gabapentin, indicated to treat seizures and other conditions, is available as an immediate-release generic and the brand name Neurontin®, as well as the extended-release brands, Gralise® and Horizant® (gabapentin enacarbil). Lyrica® (pregabalin), its generic and brand-only, extended-release Lyrica® CR have several FDA-approved indications, such as relieving pain resulting from diabetic neuropathy, fibromyalgia and shingles, in addition to treating seizures. Manufacturers of the drugs will add new safety information to the labeling of gabapentin and pregabalin products. The FDA also is requiring manufacturers to hold clinical trials assessing the potential risks. Prescribers are being asked to limit doses of gabapentin or pregabalin if they must be taken with a CNS depressant and to monitor patients taking both for any signs of respiratory distress. Patients and their caregivers should report any unusual symptoms, especially difficult breathing and a bluish color to the lips, fingers or toes. More information is in the FDA’s notification here.

Enhertu Approved for Breast Cancer

On Dec. 20, 2019, the FDA approved Daiichi Sankyo’s Enhertu® (fam-trastuzumab deruxtecan-nxki) for a certain subset of patients who have breast cancer. It will be used when metastatic breast cancer that is positive for human epidermal growth factor receptor 2 (HER2+) is inoperable or metastasizes further after at least two previous treatments with anti-HER2 drugs. Enhertu is a conjugate that links an antibody specific to HER2 with a topoisomerase inhibitor that kills cancer cells. The recommended dose is weight-based at 5.4mg/kg given as an IV infusion once every three weeks. A boxed warning and a patient Medication Guide explain that using it may cause lung conditions, including interstitial lung disease, which could be fatal. It also may damage a developing baby, so women of childbearing age should use effective contraception while being treated with Enhertu. It is expected to be launched in January 2020. Full prescribing information is here.

Dayvigo Receives FDA Approval

Eisai’s Dayvigo™ (lemborexant) tablets was approved by the FDA on Dec. 20, 2019. An orexin receptor inhibitor, it is indicated to treat adults who have insomnia. It blocks two orexin receptors (OX1R and OX2R) to help patients fall asleep and stay asleep, as well. In a clinical study that lasted six months and included nearly 1,000 participants, patients taking Dayvigo reported shorter times to fall asleep and fewer early awakenings than those taking a placebo. At the end of the trial, patients who stopped taking Dayvigo did not have rebound insomnia or symptoms of withdrawal. Patients will take one tablet, beginning with 5mg, immediately before going to bed and at least seven hours before they have to wake up. If relief is inadequate, the dose my be raised to 10mg/night. Taking a dose soon after eating may delay sleep onset. Eisai plans a launch as soon as the U.S. Drug Enforcement Agency (DEA) assigns a controlled substance schedule to Dayvigo, which usually takes about three months. No pricing plans have been announced. Prescribing information is here.

FDA Approves Caplyta to Treat Schizophrenia

Caplyta® (lumateperone – Intra-Cellular Therapies) capsules was FDA approved on Dec. 20, 2019, for treating adults who have schizophrenia. By influencing levels of three neurotransmitters (dopamine, glutamate and serotonin), Caplyta works differently from other atypical antipsychotic drugs that affect fewer neurotransmitters. Patients who took it in clinical trials scored significantly better on the Positive and Negative Syndrome Scale (PANSS) total score, a standard rating for schizophrenia symptoms. Side effects were similar for actively treated patients and those taking a placebo, except for sleepiness, which affected about 24% of Caplyta-treated patients versus 10% of those receiving a placebo and dry mouth (6% versus 2%, respectively). A boxed warning on its labeling reminds patients and prescribers that no atypical antipsychotic should be used to manage psychoses related to dementia in elderly patients because their chances of death are increased. Available as 42mg capsules to be taken once daily with food, Caplyta is expected to be introduced on the U.S. market late in the first quarter of 2020. Cost information is not available at this time. For its full prescribing information, look here.

Ubrelvy Approved to Treat Acute Migraines

The FDA approved Allergan’s Ubrelvy (ubrogepant) tablets on Dec. 23, 2019. The first oral drug in a class known as calcitonin gene-related peptide receptor (CGRP) antagonists, it is indicated to treat adults experiencing acute migraine headaches. A neuropeptide, CGRP is involved with vasodilation, inflammation and pain transmission. Recommended dosing is one 50mg Ubrelvy tablet taken at the onset of a migraine. If necessary, a second dose may be taken if migraine pain has not lessened after two hours. A 100mg tablet will be available for patients who need a stronger dose. No more than 200mg should be used in any 24-hour period, however; and using Ubrelvy to treat more than eight migraines in 30 days has not been verified as safe. Ubrelvy is the first CGRP inhibitor approved to treat migraines once the headaches have started. It does not prevent migraines, however. It will be introduced in the first quarter of 2020, but its price is still to be determined. Look here for complete prescribing information.

Expanded Indication for Lynparza

Under Priority Review, the FDA has approved AstraZeneca/Merck’s poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza® (olaparib) tablets to treat some pancreatic cancers. Specifically, it was approved on Dec. 27, 2019, for maintenance treatment of adult patients who have metastatic pancreatic cancer that has or is suspected of having deleterious germline BRCA mutations and that has not progressed following at least 16 weeks of treatment with a first-line platinum-based chemo. According to the American Cancer Society, about 57,000 Americans are diagnosed with pancreatic cancer annually and an estimated 5% to 10% of patients test positive for mutations in a BRCA gene. Because its symptoms are ambiguous, pancreatic cancer has metastasized to distant parts of the body for more than one-half of patients by the time it is discovered. Five-year survival rates for patients who have metastatic pancreatic cancer are low – ranging up to only around 12%. In the clinical trials that lead to the new indication, the chance of death or cancer worsening was reduced by 47% for patients taking Lynparza as compared to those taking a placebo. First FDA approved in 2014 to treat BRCA-mutated ovarian cancer, Lynparza later gained additional approvals for breast, fallopian tube and primary peritoneal cancers that have BRCA mutations. For all indications, the recommended dose is 300mg (two 150mg tablets) taken two times a day. Before beginning treatment, patients will be verified as having BRCA mutations with an FDA-approved diagnostic test. Here is updated prescribing information for Lynparza.

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