J&J wins FDA nod for PAH combo tablet
Drug ApprovalPhase 3Clinical ResultLicense out/in
The U.S. FDA has approved Johnson & Johnson's single-tablet combination of macitentan and tadalafil for the chronic treatment of adults with pulmonary arterial hypertension (PAH).
The treatment, branded Opsynvi, combines two approved treatments into a once-daily pill — macitentan, a dual endothelin receptor antagonist first approved by the FDA in 2013 for PAH and tadalafil, a phosphodiesterase 5 inhibitor, first approved in 2003 under the brand name Cialis for erectile dysfunction.
The new approval was based on the results from the pivotal phase 3 A DUE study, in which Opsynvi demonstrated greater reduction in pulmonary vascular resistance after 16 weeks versus tadalafil or macitentan monotherapy. Opsynvi, like macitentan, has a boxed warning due to the risk of embryo-fetal toxicity.
PAH is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation that eventually leads to heart failure.
The approval comes shortly after the FDA approved Idorsia's endothelin receptor antagonist, Tryvio, after J&J had handed the rights to the drug back to the Swiss biotech. J&J's Janssen Biotech, which had been collaborating on the drug since 2017, decided to return the rights to Idorsia, along with a $343 million payment, back in September. Once-daily Tryvio is the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives.
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