J&J's Acte­lion buy­out pays off again with ap­proval of Op­syn­vi in pul­monary ar­te­r­i­al hy­per­ten­sion

John­son & John­son scored an FDA ap­proval for Op­syn­vi, a com­bo of the en­dothe­lin re­cep­tor an­tag­o­nist Op­sum­it and the phos­pho­di­esterase 5 in­hibitor tadalafil, for the treat­ment of pul­monary ar­te­r­i­al hy­per­ten­sion.

The com­bo is ap­proved both for pa­tients in the first-line set­ting as well as those who have al­ready been treat­ed with Op­sum­it and tadalafil as sep­a­rate tablets. J&J owns Op­sum­it through its buy­out of Acte­lion and tadalafil is the ac­tive in­gre­di­ent of an Eli Lil­ly drug (Cialis) that has since hit the gener­ic mar­ket. Op­sum­it is a block­buster drug that brought in $1.9 bil­lion in 2023 and was first ap­proved in 2013 to treat pul­monary ar­te­r­i­al hy­per­ten­sion. It faces a 2025 patent cliff.

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