Sotatercept

Merck & Co’s Winrevair (sotatercept) approved by MHRA for pulmonary arterial hypertension (PAH) treatment. It improves exercise capacity in adults with PAH, acting on causes of artery narrowing. Supported by phase 3 STELLAR trial results, showing significant improvements in walk distance and reducing death or clinical worsening risk.

Regulators approved Merck’s Winrevair and BMS’s injectable cancer drug. Vertex’s Alyftrek aims to surpass Trikafta’s $8.9B sales, amidst its analgesic setback. The Novo-Catalent deal underscores significant manufacturing investment, diverging from the <$5B M&A norm. FDA sets clear expectations after controversial advanced approvals.

In 2024, the FDA approved 50 new drugs, focusing on cancer, with 15 approvals. Small molecules led with 32 approvals, followed by proteins and oligonucleotides. Notable approvals included a schizophrenia treatment and a NASH drug, marking significant advancements in therapeutic areas.

The UK’s MHRA approved Merck’s Winrevair (sotatercept) for treating pulmonary arterial hypertension, following US and EU approvals. Based on a study of 323 patients, it improves exercise capacity. Acquired via Acceleron Pharma, it targets activin protein, with sales projected to exceed $1 billion by 2025.

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2024 saw FDA approvals for innovative drugs like Tryvio for high blood pressure, Neffy for severe allergies, and Dupixent for COPD. GoodRx highlighted 19 influential drug and vaccine approvals, emphasizing their potential significant impact on human health.