Merck’s Winrevair Approved by FDA for High Blood Pressure Treatment in Adults
Major Milestone for Merck
Merck’s groundbreaking treatment for high blood pressure stemming from constriction of lung arteries has gained FDA approval. This marks a significant achievement for the pharmaceutical giant.
Market Response
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Merck’s stock surged over 5% in after-hours trading following the FDA’s announcement.
Winrevair’s Impact
The newly approved therapy, Winrevair, is designed to address pulmonary arterial hypertension (PAH), a condition impacting approximately 40,000 individuals in the United States.
Addressing a Critical Need
Jannie Oosthuizen, Merck’s U.S. Human Health business president, expressed optimism about helping patients grappling with a disease associated with a 43% five-year mortality rate.
Pricing Details
With a price tag of $14,000 per vial, Winrevair is expected to cost patients around $238,000 annually, based on usage patterns observed during trials.
Development and Future Plans
Merck aims to launch Winrevair by the end of April, following its acquisition of the drug through the purchase of Acceleron Pharma for $11.5 billion.
Therapeutic Advancements
Winrevair represents a new class of drugs targeting activin, a protein linked to increased levels of a hormone associated with PAH, securing its position as a breakthrough treatment option.
Industry Response
The FDA recently approved Johnson & Johnson’s Opsynvi for PAH treatment, underscoring the pharmaceutical industry’s commitment to addressing this debilitating condition.
Health Implications of PAH
PAH poses significant health risks due to narrowed lung arteries, leading to symptoms like high blood pressure and heart strain, potentially resulting in heart failure.
Financial Projections
Analysts predict Winrevair could generate annual sales between $3 billion to $4 billion, further solidifying Merck’s position in the cardiovascular drug market.
Clinical Efficacy
