FDA approves Merck’s pulmonary arterial hypertension treatment

The FDA has approved Winrevair (sotatercept-csr), Merck’s therapy to treat adults with pulmonary arterial hypertension (PAH). PAH is caused by the proliferation of cells in the walls of the arteries in the lungs, causing them to narrow and contract abnormally. Winrevair is a first-in-class activin signaling inhibitor. Inject subcutaneously once every 3 weeks. Winrevair will be available at select specialty pharmacies in the U.S. by the end of April, Merck officials said in a press release.

Winreair costs $14,000 per vial, and Merck officials said they expect the majority of patients will be Medicare and Medicaid patients. Approximately more than one-third of patients are expected to participate in commercial plans.

Winrevair’s approval is based on results from STELLAR’s Phase 3 study. In this trial, Winrevair with background therapy showed statistically significant and clinically meaningful improvements in 6-minute walk distance and eight of nine secondary outcome measures. The data was presented at the American College of Cardiology meeting early last year. New England Medical Journal In this study, 38.9% of patients in the Winrevair group achieved improvement at week 24, compared with 10.1% in the placebo group.

FDA approves combination therapy for pulmonary arterial hypertension

The FDA has approved Opcinbi for the treatment of adult patients with pulmonary arterial hypertension (PAH). Pulmonary arterial hypertension is a rare, progressive disease characterized by constriction of small pulmonary arteries and increased blood pressure within the pulmonary circulation. This cuts off blood flow to the lungs. According to the American Lung Association, an estimated 500 to 1,000 new cases of PAH are diagnosed each year in the United States.

Developed by Johnson & Johnson, Opsynvi is a single pill combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor. Machitentan is sold by J&J under the name Opsumit. Tadalafil is sold as a generic drug and under Lilly’s brand names Cialis for the treatment of erectile dysfunction and Adcirca for the treatment of PAH. In PAH, tadalafil relaxes blood vessels, making it easier for the heart to pump.

A J&J spokesperson said Opsimbi’s list price is comparable to Opsumit, and patients do not have to pay co-pays associated with a separate prescription for the PDE5 inhibitor. According to Drugs.com, Opsmit oral tablets 10 mg cost approximately $6,662 for a supply of 15 tablets.

FDA approves Vemlidy for children with hepatitis B

The FDA has expanded the indication of Vemlidy (tenofovir alafenamide) for patients with chronic hepatitis B virus (HBV) infection. It is currently approved to treat pediatric patients aged 6 years and older and weighing 25 kg or more. Vemlidy is already available for the treatment of adults and adolescents 12 years and older.

Vemlidy, developed by Gilead Sciences, is a targeted prodrug of tenofovir that was first approved by the FDA in 2016. Vemridi’s worldwide sales were $862 million in 2023, compared to $842 million in 2022.

According to Drugs.com, Vemlidy 25mg costs $1,528 for 30 tablets. Patients with commercial insurance may have an annual limit of $6,000 and a $0 co-pay. Gilead states in its terms and conditions that copay assistance may be reduced or discontinued if a patient’s plan includes a copay accumulator or maximizer program.

FDA approves Vafseo to treat anemia in kidney disease

The FDA has approved Vafseo (vadadustat) tablets to treat anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least three months. Approximately 500,000 adult patients receiving dialysis in the United States suffer from anemia due to chronic kidney disease. Anemia is often treated with injectable erythropoiesis-stimulating drugs, primarily administered at dialysis centers.

Vafseo, developed by Akebia Therapeutics, is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. This was designed to mimic the physiological effects of altitude on oxygen availability. At high altitudes, the body responds to reduced oxygen availability by stabilizing hypoxia-inducible factors, which may increase red blood cell production and improve oxygen delivery to tissues.

Vafseo is scheduled to be released in January 2025. Pricing was not disclosed, but the price will be commensurate with the value, Nicholas Grand, senior vice president and chief commercial officer, said on a conference call with investors.

Most patients receiving dialysis are enrolled in Medicare and Medicaid plans that are reimbursed through lump sum payments. Approximately 40% of patients eligible for treatment with Vafseo are insured through a Medicare Advantage plan.

FDA grants full approval to Elahere

The FDA has granted full approval for Elahere (milvetuximab solaftansine ginkx) to treat adult patients with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Indicated for women who have received one to three previous systemic treatment regimens.

Elahere received accelerated approval in November 2022. This is an antibody-drug conjugate that targets folate receptor alpha, a cell surface protein that is highly expressed in ovarian cancer. Approximately 35% to 40% of ovarian cancer patients express high levels of folate receptor alpha.

Elahere was developed by ImmunoGen, which was acquired by AbbVie in February 2024. Elahere’s wholesale purchase cost at launch is $6,220 per vial, and patients typically use three to four vials per cycle. This equates to between $18,660 and $24,800 per treatment cycle.

FDA issues CRL for odronectamab for lymphoma indication

The FDA has filed Regeneron’s Biologics License Application (BLA) for odronectamab for patients with relapsed/refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBC). A Complete Response Letter (CRL) has been issued.

Regeneron officials said in a press release that regulators want to address issues related to the registration status of the confirmatory test. The company has been actively enrolling patients in multiple Phase 3 trials of odronectamab as part of the OLYMPIA program. This program includes both a dose determination and confirmation portion. Enrollment for the dose-finding part has begun, but the CRL indicates that the confirmation part of these trials is ongoing and a timeline for completion should be agreed before resubmission.

Odronestamab is an investigational CD20xCD3 bispecific antibody designed to target both CD20- and CD3-expressing T cells on cancer cells.