FDA Approved Drugs: April 2020

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

Sarclisa Approved to Treat Multiple Myeloma

About two months before its scheduled action date, Sarclisa® (isatuximab-irfc – Sanofi) was given approval from the FDA on March 2, 2020. A CD38-directed cytolytic antibody, it is to be used along with Pomalyst® (pomalidomide) and dexamethasone (pom-dex) for the treatment of adults who have multiple myeloma that already has been treated two or more times with Revlimid® (lenalidomide) and a proteasome inhibitor, such as bortezomib. It will be administered by intravenous (IV) infusions of 10mg/kg once every week for four weeks and then once every other week. Launch is expected soon at a wholesale acquisition cost (WAC) of $650/100mg and $3,250/500mg. For a patient who weighs 80kg (176 pounds), the WAC for one infusion is $5,200. In the phase III ICARIA-MM clinical study, 60.4% of about 150 patients treated with Sarclisa plus pom-dex responded at least partly to treatment, but only 35.3% of around 150 other patients receiving only pom-dex showed a response. Additionally, the average of progression-free survival (PFS) time for patients given all three drugs was nearly one year, as opposed to about six and one-half months for patients using pom-dex. The risk of cancer worsening or death was decreased by around 40% in the triple-drug group, as well. Neutropenia (insufficiency of specific white blood cells) occurred for 96% of patients treated with Sarclisa and pom-dex; 57% developed upper respiratory tract infections. Over 30% had pneumonia or infusion-related responses, and 10% of patients using all three drug dropped out of the study due to adverse reactions. Sarclisa has had an Orphan Drug designation since May 2014 for treating multiple myeloma. For its full prescribing information, look here.

MedWatch Update


On March 4, 2020, the FDA required manufacturers of products containing montelukast to intensify a warning about possible mental health problems that may be associated with its use. Available as a brand, Singulair®, and multiple generics, montelukast tablets are approved to treat and prevent asthma and to treat allergies. For some of its indications, it can be used for children as young as six months old. Now, all montelukast products must include a boxed warning that it may cause mood changes or behavioral issues. Patients and caregivers are cautioned to watch for signs of new or increased anxiety, confusion, depression, irritability, restlessness, sleeping problems and other unusual behaviors while taking it. If moods or behaviors change significantly, montelukast should be stopped and the patient should consult with a medical provider. Healthcare professionals are advised to be sure patients and their caregivers know about the potential concerns. When prescribing to treat allergies, they also are encouraged to reserve montelukast only for patients who have symptoms that are not relieved by other allergy medications. More information is in the FDA’s safety notice. 

Isturisa Approved for Cushing’s Disease

Isturisa® (osilodrostat) tablets was approved by the FDA on March 6, 2020. It is indicated to treat adults who have Cushing’s disease and who either cannot have surgery to correct the condition or have had surgery that was not effective. The first in a new drug class, Isturisa interferes with the effects of an enzyme to restrict the body’s production of cortisol. Constant excess cortisol causes a number of symptoms that include a distinctive roundness of the face, obesity in the upper body and a bowed upper back. To treat Cushing’s disease, Isturisa will be taken at a starting dose of 2mg two times a day. If needed, doses may be increased by up to 2mg per dose — over two-week intervals — to a maximum of 30mg twice daily. Novartis developed Isturisa and submitted the new drug application (NDA) to the FDA. However, an Italian pharmaceutical company, Ricordati, will be distributing it in the U.S. Isturisa is expected to be released in the second or third quarter of 2020, but the price has not yet established. Look here for full prescribing information.

FDA Approves a New Indication for Ofev

On March 9, 2020, Boehringer Ingelheim gained an additional indication for its kinase inhibitor, Ofev® (nintedanib) capsules. Originally FDA approved in 2014 for the treatment of idiopathic pulmonary fibrosis (IPF), Ofev also was approved in 2019 for decreasing the rate of pulmonary function deterioration for treating patients who have systemic sclerosis-associated interstitial lung disease (SSc-ILD). Its new approval is for progressing phenotypes of chronic fibrosing interstitial lung diseases (ILD), a collection of similar lung conditions that currently have no other approved drug treatments available. Although they may have different causes, all the diseases that Ofev treats can worsen quickly, scar the lungs, cause shortness of breath and, eventually, result in respiratory failure. For all its indications, the recommended dose is 150mg taken with food twice a day -- about 12 hours apart. Because it may cause liver damage, liver function tests should be conducted prior to initiating treatment and while patients receive therapy with Ofev. The new approval was granted under the FDA’s Priority Review and Breakthrough Therapy programs, which both accelerate the review and approval process for drugs that meet unfilled needs. For Ofev’s complete prescribing information, look here.

New Indication for Opdivo and Yervoy

Used together, the monoclonal antibodies, Opdivo® (nivolumab) and Yervoy® (ipilimumab), both made by Bristol Myers Squibb, now are indicated to treat patients who have had prior treatment with Nexavar® (sorafenib – Bayer) for hepatocellular carcinoma (HCC). The FDA gave the new indication  Accelerated Approval on March 10, 2020. Additional positive clinical trial results will be needed for full approval. Opdivo, a programmed death receptor-1 (PD-1) blocker, lessens cancer cells’ ability to evade T-cell attacks. Yervoy attaches to a specific antigen to boost T-cell production and activity. In the clinical trial that resulted in the approval, approximately one-third of 49 patients who were treated with the two-drug combination responded at least partly to treatment. Of those who did show a response, 88% maintained it for at least six months and 31% for two years or longer. Recommended dosing is 1mg/kg of Opdivo given over 30 minutes as an IV infusion and followed on the same day by a 30-minute IV infusion of 3mg/kg of Yervoy. Combination treatments are given once every three weeks for up to four cycles. If the drugs are tolerated and the cancer does not progress, treatment continues with only Opdivo at 240mg once every two weeks or 480mg once a month. Individually, Opdivo and Yervoy each have indications as monotherapy for different types of cancer. In combination, they are FDA approved to treat some types of colorectal cancer, malignant melanoma and renal cell carcinoma (RCC). Yervoy has a boxed warning that concerns its potential to cause immune-mediated reactions that could damage the intestines, liver, nerves, skin or other organs. Patients using it should be monitored for any signs of immune-mediated reactions prior to each dose of Yervoy. Revised prescribing information is here for Opdivo and here for Yervoy.

Generic Launched for Some Strengths of Zortress

Hikma Pharmaceuticals has launched the first generics for Zortress® (everolimus – Novartis) tablets, 0.25mg. 0.5mg and 0.75mg. Everolimus is an immunosuppressant used in small doses to prevent organ rejection for adults who are at low to moderate risk after having a kidney transplant. Treatment, which begins immediately after surgery, also includes Simulect® (basiliximab), cyclosporine and a corticosteroid. Along with a corticosteroid and tacrolimus, everolimus also can be started at least one month after the procedure to prevent rejection of a transplanted liver. Doses are taken twice a day beginning at 0.75mg/dose for patients who have had kidney transplants and 1mg/dose for liver transplant recipients. A boxed warning cautions that patients using everolimus may be more likely to have infections and they may develop cancer. Additionally, the chance of blood clots and nephrotoxicity may be higher for patients who have received a kidney transplant. Only specialist physicians who are trained and experienced the use of everolimus should prescribe it. According to IQVIA, U.S. sales of the three strengths that now are available as generics amounted to approximately $150 million between February 2019 and the end of January 2020. The 1mg tablets of Zortress remain brand-only.

Additional Herceptin Biosimilar Available

Teva Pharmaceuticals and Celltrion Healthcare launched Herzuma® (trastuzumab-pkrb) for injection, their biosimilar to Herceptin® (trastuzumab – Genentech), on March 16, 2020. Like Herceptin and its other FDA-approved biosimilars, Herzuma is indicated to treat breast cancers and metastatic stomach cancers (gastric or gastroesophageal junction adenocarcinomas) that overexpress the HER2 gene (HER2+). It is given as an 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. Other currently available biosimilars are Trazimera (trastuzumab-qyyp), launched in the United States by Pfizer on Feb. 15, 2020; Ogivri (trastuzumab-dkst – Mylan/Biocon Biologics), which was introduced on Dec. 2, 2019; and Kanjinti (trastuzumab-anns), a biosimilar from Amgen and Allergan that was released on July 18, 2019. None of the biosimilars can be substituted for Herceptin or for each other. Herzuma was introduced at a wholesale acquisition cost (WAC) of $1,405.50 for a 150mg vial and $3927.00 for 420 mg — 10% less than the WAC for Herceptin, but above the WACs for Trazimera and Kanjinti. For Herzuma’s full prescribing information, look here.

Pediatric Indication for Epclusa

Epclusa® (sofosbuvir/velpatasvir - Gilead) tablets was FDA approved on March 19, 2020, for treatment of children who are at least six years old or who weigh at least 17kg (about 37 pounds). First approved for adults in June 2016, it has a 12-week recommended course to treat all six known genotypes of hepatitis C. Gilead estimates that up to 46,000 children could be candidates for its use. Pediatric dosing depends on the child’s weight, with those weighing under 30kg taking one tablet containing sofosbuvir 200mg/velpatasvir 50mg per day and those weighing 30kg or more taking the adult dose of sofosbuvir 400mg/velpatisvir 100mg per day. Children who have severe cirrhosis will need to take ribavirin, as well, also adjusted for weight. A boxed warning cautions that using Epclusa could activate hepatitis B virus (HBV) for patients who have or who have had HBV. Patients should be tested for HBV before, during and for several months after treatment. For revised prescribing information, go here.

MedWatch Update

Sodium-Glucose Cotransporter-2 Inhibitors

The FDA is requiring label changes for all drugs that contain a sodium-glucose cotransporter-2 (SGLT2) inhibitor. Patients who take the drugs, which are used to treat type 2 diabetes, should stop taking them before having surgery because the risk of ketoacidosis may be increased. Ketoacidosis is a potentially life-threatening accumulation of acids and other chemicals in the blood when diabetes is not managed properly. Patients will need to have alternate treatment to control blood sugar after the SGLT2 inhibitor is discontinued and until their food consumption is back to normal after the surgery. SGLT2 inhibitors approved in the U.S. are AstraZeneca’s Farxiga® (dapagliflozin), Qtern® (dapagliflozin/saxagliptin) and Xigduo XR (dapagliflozin/metformin extended release); Eli Lilly’s Jardiance® (empagliflozin), Glyxambi® (empagliflozin/linagliptin), Synjardy® (empagliflozin/ metformin), Synjardy® XR (empagliflozin/metformin extended release) and Trijardy (empagliflozin/linagliptin/metformin); Janssen’s Invokana® (canagliflozin), Invokamet® (canagliflozin/metformin) and Invokamet XR® (canagliflozin/metformin extended release); and Merck’s Steglatro (ertugliflozin), Segluromet (ertugliflozin/metformin) and Steglujan (ertugliflozin/sitagliptin). Products containing ertugliflozin should be stopped four days prior to the scheduled procedure; the others should be stopped three days before. For more information, please see the FDA notice.

Eucrisa’s Indication Extended

The pediatric indication for Eucrisa® (cisaborole) ointment, 2% was expanded by the FDA on March 23, 2020. Pfizer’s topical phosphodiesterase 4 (PDE-4) inhibitor, first FDA approved in late 2016 to treat mild-to-moderate atopic dermatitis for patients age two years and older, now can be used for treating children as young as three months old. Also known as eczema, atopic dermatitis includes a group of chronic skin diseases that involve inflammation and cause itchy, irritated bumps, crusts and scales on the skin. It usually begins in childhood, with an estimated 11% of American children having it and most continuing to have symptoms into adulthood. Approximately 45% of patients have their first outbreaks before the age of six months, according to the National Eczema Association. Symptoms may improve and worsen unpredictably, but inflammation and scratching eventually can thicken and toughen the skin. To treat atopic dermatitis, Eucrisa is applied lightly to affected areas twice a day. Updated prescribing information for Eucrisa may be found here.

Cipla Launches Generics for Nexium Oral Solution

On March 23, 2020, Cipla’s AB-rated generics to three strengths (10mg, 20mg and 40mg) of AstraZeneca’s Nexium® (esomeprazole magnesium) for oral suspension were approved by FDA. Esomeprazole magnesium is a proton pump inhibitor (PPI) approved to treat gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions, such as Zollinger-Ellison syndrome. It also is indicated to decrease the risk of both stomach ulcers from the use of non-steroidal anti-inflammatory drugs (NSAIDs) and the return of ulcers in the upper part of the small intestine. The prescription-only generics, available in cartons of 30 individual-dose packets, were shipped immediately, but their pricing information is not yet available. 

Zeposia Approved for Multiple Sclerosis

Bristol Myers Squibb (BMS) received FDA approval on March 25, 2020, for Zeposia® (ozanimod) capsules. It was approved to treat adult patients with relapsing forms of multiple sclerosis (RMS), including relapsing-remitting multiple sclerosis (RRMS), clinically isolated syndrome (CIS) and active secondary progressive multiple sclerosis (SPMS). A sphingosine 1-phosphate (S1P) receptor modulator, Zeposia blocks two of the five S1P receptors within the central nervous system (CNS) to reduce inflammation. In the SUNBEAM and RADIANCE clinical trials of 2,666 patients with RMS, Zeposia treatment resulted in a relative reduction in annualized relapse rate of 48% at one year and 38% at two years, when compared to Avonex® (interferon beta-1a). It also is being studied for treating ulcerative colitis and Crohn’s disease. Before treatment begins, prescribers will need to do a baseline assessment that includes complete blood count, electrocardiogram (ECG), liver function tests, ophthalmic assessment, immunization history and medication history for each patient. After the assessment, patients will follow a 7-day dose escalation schedule until they are up to a recommended maintenance dose of 0.92mg orally once daily with or without food. Although taking Zeposia may slow heartbeats, it does not require first-dose monitoring like its main competitors, Novartis’ Gilenya® (fingolimod) and Mayzent® (siponimod) do. Its launch is being delayed due to the COVID-19 pandemic. Pricing information is not available at this time. BMS will continue to evaluate the situation and keep patients and the health community informed of launch plans. For complete prescribing information, look here.

MedWatch Update


In an FDA communication and an associated letter for health professionals, Mylan Pharmaceuticals is cautioning prescribers, pharmacies, patients and caregivers of potential safety issues with EpiPen®, EpiPen Jr® and their authorized generics (epinephrine auto-injectors). A blue safety release on some of the devices may be slightly high — sometimes causing the device to trigger early when it is removed from the storage tube or if the user twists the release sideways instead of pushing it straight. An individual preparing to use an EpiPen should be sure that the safety release is tight with the top of the device, and then hold the auto-injector firmly in one hand with the orange end pointing down. The release should be pulled straight up with the other hand. Additionally, a small defect in the storage tubes for a very few devices may cause them to get stuck in the tubes, possibly resulting in additional time to pull out the auto-injector. Both issues could delay or prevent an injection. Patients or their caregivers should check each device they have to assure that it slides easily out of its tube and that the safety release is not sticking up from the top of the auto-injector. If either problem is found, the patient or caregiver should call Mylan at 800.796.9526 for directions on how to return the defective device for a free replacement. 

Pediatric Indication Approved for Taltz

On March 26, 2020, Taltz® (ixekizumab – Eli Lilly) subcutaneous (SC) injection received FDA approval for treating moderate-to-severe psoriasis for patients as young as six years old. Taltz decreases inflammation by binding to interleukin (IL)-17A and inhibiting interactions with the IL-17 receptor. First FDA approved to treat adults who have psoriasis, Taltz later got additional approvals to treat adults who have psoriatic arthritis and ankylosing spondylitis. It can be used alone or in combination with methotrexate or another conventional disease-modifying antirheumatic drug (cDMARD), but not along with other biologic DMARDs. It is available in single-use, pre-filled autoinjectors and syringes, each containing 80mg. For patients who weigh less than 50kg (110 pounds), once monthly dosing is based on body weight, beginning at 20mg, after a doubled loading dose. Because the risk of infections may be increased among patients using it, patients should test negative for tuberculosis (TB) before beginning therapy. Patients who are using Taltz should be monitored for signs of TB and for developing or worsening inflammatory bowel disease (IBD), as well. Here is updated prescribing information for Taltz.

Imfinzi Receives Additional FDA Approval 

The FDA approved a new indication on March 27, 2020, for AstraZeneca’s programmed death ligand 1 (PD-L1) inhibitor, Imfinz(durvalumab). It originally was FDA approved in May 2017 for treating patients whose locally advanced or metastatic urothelial carcinoma (cancer of the bladder, ureter and/or urethra) progresses during or following platinum-containing chemotherapy. In February 2018, it gained a second indication to treat stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery and that has not worsened after the patient underwent both platinum-based chemotherapy (chemo) and radiation treatment. Now, it is approved as first-line treatment, along with chemo that includes etoposide and either carboplatin or cisplatin, for adults who have extensive-stage small cell lung cancer (ES-SCLC). The recommended dose for the new indication is 1,500mg of Imfinzi as a one-hour IV infusion that is given before the chemo drugs once every three weeks. After four doses, the chemo is stopped and the Imfinzi continues at 1,500mg once a month until the cancer gets worse or the treatment becomes too harsh for the patient to bear. For revised prescribing information, go here.


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