October 10th 2024
The results come from a phase IIa safety and tolerability study. The drug’s developers say they are working with regulatory authorities in hopes of launching a pivotal trial.
Analysis Supports Initial Combination Therapy for Patients with PAH, Comorbidities
July 21st 2024Patients with pulmonary arterial hypertension and cardiopulmonary comorbidities are typically started on monotherapy, but new data suggest some patients would do well with initial combination therapy.
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FDA Updates for Week of March 25: Two Approvals for PAH
March 30th 2024This week, the FDA approved two therapies for pulmonary arterial hypertension: Merck’s first in class therapy Winrevair and J&J’s oral combination tablet Opsynvi. The agency also approved Vafseo, a new treatment for anemia in kidney disease. The FDA granted full approval to the cancer drug Elahere and extended the indication of Vemlidy to children. Regulators also issued a CRL for odronextamab for lymphoma indications
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FDA Approves Combination Therapy for PAH
March 25th 2024J&J’s Opsynvi is single-tablet combination of macitentan, an endothelin receptor antagonist, and tadalafil, a PDE5 inhibitor. It will be priced on parity with Opsumit, which is also a J&J product to treat patients with pulmonary arterial hypertension.
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