FDA Approved Drugs: March 2020

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

Pizensy Receives FDA Approval

A new osmotic laxative, Pizensy (lactitol – Braintree Laboratories) was approved by the FDA on Feb. 12, 2020. Osmotic laxatives work by attracting more water into the intestines, which softens solids and makes them easier to eliminate. Pizensy is approved to relieve chronic idiopathic constipation (CIC) for adults. To be dispensed as a powder in multi-dose bottles or single-dose packets, the recommended dose is 20gm mixed into 4 ounces to 8 ounces of water, coffee, or another drink once a day with food. Doses may be lowered to 10gm/day if stools are too soft. Because Pizensy may interfere with the absorption of other drugs, patients should take it two hours or more before other drugs or they should wait two hours or more after taking it to take other medications. No launch or pricing plans have been released. Here is prescribing information for Pizensy.

MedWatch Update

Belviq/Belviq XR

Following a request by the FDA, Eisai, Inc. is removing Belviq® (lorcaserin) tablets and Belviq XR® (lorcaserin extended-release) tablets from sale. They were approved to be used along with diet and exercise to manage weight for patients who are obese or who are overweight and who also have other significant health issues, such as diabetes and hypertension. In examining the results of post-marketing studies, the FDA discovered an unexpected relationship between taking lorcaserin and developing cancer. Patients who took it for long periods seem to be most at risk. The FDA is advising patients to stop taking Belviq and Belviq XR, to dispose of any remaining tablets and to discuss other treatment options with their doctors. Prescribers should counsel patients on alternate weight-loss methods. No additional or special cancer screenings are recommended, however. For detailed information, please see the FDA’s notice here.

New Contraceptive Patch Approved

Agile Therapeutics received FDA approval on Feb. 14, 2020, for Twirla® (levonorgestrel/ethinyl estradiol) transdermal system. Each Twirla patch releases a low daily dose of an estrogen and a progestin to provide contraception. One patch is applied to clean, dry skin of the abdomen, back, buttocks or lower chest once each week for three weeks and then no patch is needed for the fourth week. Twirla is not approved for women who have a body mass index (BMI) over 30kg/m2 and its effectiveness may be limited for women whose BMI is between 25kg/m2 and 30kg/m2. An additional boxed warning specifies that its risk of causing blood clots means it should not be used by women who are older than 35 years of age and who smoke. Agile plans to begin distributing Twirla in the fourth quarter of 2020, but its price has not yet been disclosed. Check here for its prescribing information.

Additional Biosimilar to Herceptin Launched

Trazimera (trastuzumab-qyyp), a biosimilar for Herceptin® (trastuzumab - Genentech) was launched by Pfizer on Feb. 15, 2020. It is used to treat breast cancers and metastatic stomach cancers (gastric or gastroesophageal junction adenocarcinomas) that overexpress the HER2 gene (HER2+). Mainly given as 30-minute IV infusions after an initial 90-minute infusion, doses vary on schedules that also differ according to the type of the cancer being treated. At $80.74 for 10mg ($3,671.64 for each 420mg vial), the wholesale acquisition cost (WAC) for Trazimera is 22% less than the WAC for Herceptin. All trastuzumab products have boxed warnings that they may cause birth defects, heart failure, respiratory distress or severe allergic reactions. In addition to sharing the market with Herceptin, Trazimera will compete with Kanjinti (trastuzumab-anns – Amgen/Allergan), the first Herceptin biosimilar to be released in the United States in June 2019, and with Ogivri (trastuzumab-dkst – Mylan/Biocon), introduced last December. None of the biosimilars is interchangeable with Herceptin or with each other. Here is full prescribing information for Trazimera.

FDA Approves Anjeso

Anjeso (meloxicam injection – Baudax Bio) was FDA approved on Feb. 20, 2020. It is an NSAID indicated to treat moderate-to-severe pain for adults. Patients in the clinical trials that lead to its approval had undergone surgeries ranging from bunion removal to major abdominal procedures. Although oral formulations of meloxicam have been available in the U.S. for about 20 years, Anjeso is the first injectable form to be FDA approved. It can be used by itself, but it does not begin to work immediately, so it also is approved for use with short-term pain relievers that are not in the NSAID class. Dosage is one vial (30mg) given as IV bolus push per day. It should be used only as long as the patient needs relief for severe pain. All products that contain an NSAID have a warning that using them may increase the risk of cardiovascular (CV) events, such as heart attacks, and/or gastrointestinal (GI) side effects, such as stomach ulcers. Baudax plans to market Anjeso late in April or early in May. Its cost is not yet available. Check here for its complete prescribing information.

Nexletol Approved to Lower Cholesterol

On Feb. 21, 2020, the FDA approved Esperion’s Nexletol (bempedoic acid) tablets. The first drug in a new class, adenosine triphosphate (ATP) citrate lyase (ACL) inhibitors, it is used along with a diet and the highest tolerated dose of an HMG-CoA reductase inhibitor (statin) to treat adults who have heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) and who are already taking a statin but who require additional lowering of LDL cholesterol (LDL-C). It should not be used with more than 20mg/day of pravastatin or 40mg/day of simvastatin. HeFH is an inherited disorder thought to affect about one American in 500. For patients who have it, genetic mutations cause cholesterol to be retained, leading to elevated blood levels of LDL-C despite diet, exercise and aggressive drug treatment. ASCVD is a very common condition that involves the accumulation of cholesterol plaques in the arteries. It can result in a heart attack, stroke or other adverse CV events. In the United States, as many as 15 million patients may have HeFH, ASCVD or both. Nexletol’s recommended dose is 180mg (one tablet) once a day. Launch is planned for March 30, 2020, at a wholesale acquisition cost of about $3,650 per year of therapy. Full prescribing information may be found here.

Vyepti Approved for Migraine Prevention

Lundbeck’s Vyepti (eptinezumab-jjmr) was approved by the FDA on Feb. 21, 2020, as the first IV prevention treatment for migraine in adult patients. Vyepti, a humanized monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), is given by IV infusion at a recommended dose of 100mg over 30 minutes once every three months. Some patients may need to increase the dose to 300mg, if relief is not adequate. In clinical trials that involved over 2,000 individuals, significantly more patients receiving Vyepti showed improvement on the first day after infusion compared to those given a placebo. Actively treated patients had fewer migraines over the following week, as well. Vyepti does not carry a black box warning but its label does advise about some relatively mild hypersensitivity reactions that still led to discontinuation of treatment by a few patients. To be introduced in April 2020, Vyepti, which does require dilution before administration, will be available in 100mg/mL single-use vials. Lundbeck has not disclosed any plans for cost. For full prescribing information, look here.

Expanded Indication for Trulicity

Trulicity® (dulaglutide), Eli Lilly and Company’s long-acting glucagon-like peptide-1 (GLP-1) agonist, got a new indication from the FDA on Feb. 21, 2020. Self-administered once-weekly as an SC injection, Trulicity originally was FDA approved in 2014 for use along with diet and exercise to manage blood sugar levels for adults who have type 2 diabetes. It now can be used to decrease the likelihood of CV events, such as heart attacks and strokes, in adult patients with type 2 diabetes who have established CV disease or multiple CV risk factors. All GLP-1 drugs carry a boxed warning that tumors of the thyroid gland (thyroid C-cell tumors) have occurred among laboratory rodents treated with some GLP-1 receptor agonists in preclinical studies. Whether or not humans using them develop thyroid C-cell tumors, such as medullary thyroid carcinoma (MTC), is not yet known. Patients who have MCT, individuals with close family members who have thyroid C-cell tumors and patients who have Multiple Endocrine Neoplasia syndrome type 2 (tumors in more than one gland) should not use Trulicity. Its complete prescribing information is here.

First Generic Approved for ProAir HFA

On Feb. 24, 2020, the FDA approved Perrigo Pharmaceuticals’ AB-rated generic to Teva’s ProAir® HFA (albuterol) Inhalation Aerosol. Similar to the brand’s indication, Perrigo’s generic is indicated to prevent and treat bronchospasms for patients who are at least four years old and who have reversible obstructive airway disease. Both also are approved to prevent exercise-induced bronchospasms (EIB) for patients age four years and older. Also like the branded product, the generic will be available in metered-dose inhalers containing 200 doses of 90mcg each. Perrigo and its manufacturing partner, Catalent Pharma Solutions, already have launched a small supply of albuterol inhalation aerosol and they plan to increase production to full capacity by the fourth quarter of 2020. Wholesale acquisition cost (WAC) is not yet available. According to Teva’s 2019 annual report, North American sales of the ProAir franchise (including two other brands, but not including the authorized generic [AG]) were $274 million. However, IQVIA estimated that total global sales for the last 12 months amounted to $1.4 billion.

Nexlizet Approved by the FDA

On Feb. 26, 2020, the FDA approved Esperion’s Nexlizet(bempedoic acid/ezetimibe) tablets. Nexlizet is the first once-daily, non-statin, LDL cholesterol-lowering combination. It is indicated for use in adults who have HeFH or ASCVD and who are taking a statin, but who require further lowering of LDL cholesterol (LDL-C). Bempedoic acid, an ATP Citrate Lysase (ACL) inhibitor, was approved as a single drug earlier in February under the trade name Nexletol. Ezetimibe, available as a generic, works by blocking absorption of cholesterol in the small intestine. Compared to placebo, Nexlizet lowered LDL-C by an average of 38% in clinical trials. Although Nexlizet does not carry a boxed warning, its label does caution that a few patients experienced high serum uric acid levels that led to gout and a few patients suffered tendon ruptures. Notable drug interactions include simvastatin in daily doses of 20mg or higher and pravastatin at 40mg or more. Patients should be monitored when taking cyclosporine, which could affect blood levels of both drugs, and fibrates, which could cause gallstones if taken together. Nexlizet is planned for launch in July 2020. Full prescribing information can be found here.

Barhemsys Receives FDA Approval

Acacia Pharma Group was granted FDA approval on Feb. 26, 2020, for Barhemsys® (amisulpride) injection. Known as a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, it is an IV antiemetic indicated to prevent post-operative nausea and vomiting (PONV) either alone or along with another anti-nausea drug, such as ondansetron. The recommended dose to prevent nausea and vomiting before a surgical procedure is 5mg infused over one to two minutes. The dose is 10mg, administered over one to two minutes, for the treatment of PONV. Barhemsys is not approved for use in pediatric patients. Beginning in the second half of 2020, it will be available as single-dose vials containing 5mg/2mL. Pricing has not yet been announced. Its prescribing information is here.

Nurtec ODT Approved for Acute Migraine

An oral CGRP antagonist, Nurtec ODT (rimegepant orally-disintegrating tablets), was approved by the FDA on Feb. 27, 2020. It is indicated to treat adults who have acute migraine headaches, but not to prevent migraines. The recommended dose is one 75mg tablet, dissolved on or under the tongue, once a headache starts or once the patient has signs that a migraine is about to begin. Only one tablet should be used per day and using more than 15 tablets per month has not been proven safe. In the clinical studies of its use, Nurtec ODT moderated pain to tolerable levels within two hours for most patients. Relief generally lasted for 48 hours or longer for the majority of patients and 86% of them did not need to use another pain reliever for at least 24 hours after they took Nurtec ODT. Beginning in March, the manufacturer, Biohaven Pharmaceuticals, will market cartons containing eight blister-packed tablets, but the WAC has not been released, yet. Here is full prescribing information.

Generic to Daraprim Approved by FDA

On Feb. 28, 2020, the FDA approved the first AB-rated generic to Vyera Pharmaceutical’s Daraprim® (pyrimethamine) tablets. Daraprim is known for its controversial high price. Cerovene received approval for its generic through the FDA’s accelerated review system known as the Drug Competition Action Plan (DCAP), an initiative started in 2017. Pyrimethamine tablets are indicated for treating toxoplasmosis (toxoplasma gondii) when used in combination with a sulfonamide antibiotic. Toxoplasmosis is a parasite that can cause damage to eyes and other organs when a person consumes contaminated water, infected cat feces or undercooked meat and shellfish. Patients most at risk for toxoplasmosis are pregnant women and those with a weakened immune system; such as patients who have had an organ transplant or those living with HIV. Pyrimethamine will be available in 25mg oral tablets, similar to Daraprim. Pricing and availability have not yet been announced by Cerovene. You can read about the FDA approval here. Information about the FDA Drug Competition Action Plan can be found here.

Riomet ER Launched

Following its FDA approval in August 2019, Sun Pharma’s Riomet ER(metformin for extended-release oral suspension) now is available in the U.S. Like immediate-release Riomet® (metformin) oral solution, which needs to be taken two or three times a day, Riomet ER is indicated along with diet and exercise for treating patients at least 10 years old who have type 2 diabetes. Sun estimates that around 40% of the approximately 24 million American adults age 45 years and older who have type 2 diabetes also have some degree of difficulty swallowing tablets or capsules. Many small children also are more receptive to a liquid drug than to a solid dose form. Dispensed in 16-ounce bottles that are either grape or cherry flavored, Riomet ER has an initial recommended dose of 500mg once daily, which can be increased to as much as 2000mg once a day, if needed. It is taken along with the last meal of the day. All medications that contain metformin have a boxed warning that taking it may cause lactic acidosis, the buildup of excessive acid in the blood. Prescribing for Riome is here.

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