Fierce Pharma March 25, 2024
With the FDA expected this week to approve a first-in-class treatment from Merck for pulmonary arterial hypertension (PAH), Johnson & Johnson has beaten its New Jersey rival to the punch with a nod from the U.S. regulator for its newest PAH treatment.
The FDA has signed off on Opsynvi, a tablet that combines J&J’s Opsumit (macitanten) and United Therapeutics’ Adcirca (tadalafil), which are commonly prescribed together to treat the condition. PAH is a rare, rapidly progressing disease in which the blood vessels narrow in the lungs, increasing blood pressure and leading to heart failure.
Opsynvi becomes the only once-daily, single-tablet combination therapy for PAH. It can be used by newly diagnosed patients who are treatment-naïve. It can also be used...
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