U.S. Food and Drug Administration Tuesday officially recognized a drug from Merck Intended to treat progressive and life-threatening Lung condition This is a win for both drugmakers and patients with this rare disease.
The agency approved the therapy, which will be called Winrevair, to treat adults with pulmonary hypertension.This decision is a big step for roughly 40,000 people There are many people living with this disease in the United States because Winrevair is the first drug to target the underlying cause of the disease.other Available medications Only helps control symptoms.
This condition is when the small blood vessels in the lungs narrow. This causes increased blood pressure in the arteries that carry blood from the heart to the lungs, damaging the heart and causing limitations in physical activity. According to Merck, the patient mortality rate within five years from diagnosis is 43%.
According to news released by Merck, Winrevair is expected to be launched on some specialty pharmacies in the United States by the end of April. The drug is injected every three weeks and distributed in single- or two-bottle kits.
The drug sells for $14,000 per vial before insurance, a Merck spokesman said in a statement. But the company has a program that provides out-of-pocket and out-of-pocket assistance to qualifying patients.
Winrevair is designed to be used alongside existing treatments to improve exercise capacity, reduce the severity of PAH and reduce the risk of disease progression.
The approval is crucial for Merck, which is working to diversify its revenue sources as its best-selling cancer immunotherapy Keytruda loses market exclusivity in 2028.
JPMorgan analyst Chris Schott estimated in a report this month that Winrevair’s global annual sales will reach about $5 billion by 2030, making it one of Merck’s “biggest growth drivers.”
“This is a really great opportunity for the company, but more importantly, a very important opportunity for patients,” Eliav Barr, Merck’s chief medical officer, told CNBC. He noted that the drug will be a treatment for PAH A “paradigm shift” for patients.
through which the company acquired the rights to Winrevair $11.5 billion acquisition Acceleron Pharma was founded in 2021. At the time, Merck estimated that the PAH market would reach approximately $7.5 billion by 2026.
FDA approval based on data from one agency late stage trialthe study followed more than 300 patients in moderate stages of PAH who were already taking another drug to treat vascular disease.
Research finds Winrevair After 24 weeks of the trial, patients were able to walk approximately 40.8 meters more in 6 minutes when combined with existing therapy compared with patients who received a placebo.
“There’s been a huge improvement in people’s ability to exercise and move around,” Barr said. “People are very, very homebound because of this disease. They’re short of breath and can’t move.”
Winrevair also significantly improved eight of nine secondary objectives in the study over the existing drug. This includes an 84% reduction in the risk of death or worsening of the condition compared with existing drugs alone.
Serious and serious adverse events are Unusual According to the trial, a group of patients taking Winrevair was compared to a group of patients taking a placebo. Common side effects include nosebleeds, headaches and rashes.
A significant advantage of Winrevair is that it can be injected under the skin by a patient or caregiver with appropriate training from a healthcare provider. At the same time, some existing treatments for pulmonary hypertension must be administered by medical professionals at an infusion center.
“One of the things we hear very loud and very clear from patients and doctors is that they want something that you can get At home,” Barr said.
Merck is continuing to study Winrevair in other Phase 2 and Phase 3 trials.
These tests include Later research Indicated for patients with more advanced PAH disease and within the first year after diagnosis. Merck said it expects the trials to be completed around 2025 and 2026.
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