Johnson & Johnson’s plan to expand decade-old pulmonary hypertension med Opsumit has hit a snag.
J&J’s Janssen has decided to stop a phase 3 trial for a 75-mg dose of macitentan in patients with chronic thromboembolic pulmonary hypertension (CTEPH). The company pulled the plug after an independent data monitoring committee performed an interim analysis and figured the trial wouldn’t succeed.
Macitentan, given at 10 mg daily, won approval in 2013 under the brand name Opsumit for treating pulmonary arterial hypertension (PAH). PAH and CTEPH are slightly different diseases, but both feature abnormally high blood pressure in the arteries of the lungs. The results from the high-dose trial, dubbed MACiTEPH, won’t affect the marketed product, J&J said.
Separately, J&J is trying to show that the higher dose works better than the FDA-approved 10-mg version in PAH. That study, coded UNISUS, remains ongoing with an estimated primary completion date next month, according to ClinicalTrials.gov.
The New Jersey pharma giant is also seeking FDA approval for a fixed-dose combination of Opsumit and Eli Lilly’s United Therapeutics-partnered Adcirca in PAH. An approval there would add patients with WHO-functional group 2 to 3 disease to Opsumit’s reach, on top of its current group 1 nod. Health Canada in 2021 approved the combo regimen as Opsynvi.
The MACiTEPH trial flop deprives J&J of an opportunity to challenge Merck and Bayer’s Adempas, which in 2013 became the first drug approved to treat CTEPH. J&J, through a collaboration with Nippon Shinyaku, did win a CTEPH approval in Japan for Uptravi in 2021.
Despite a broader label in both PAH and CTEPH, Adempas lags both Opsumit and Uptravi in sales. As the PAH leader, Opsumit ginned up $1.78 billion sales in 2022, up 2.6% year over year at constant currencies. Adempas’ sales dropped 17.2% at unchanged exchange rates to 652 million euros (about $700 million), Bayer said. For its part, Merck reported $238 million in sales from the drug.
Meanwhile, the PAH field could soon feature a new player. Sotatercept, the centerpiece in Merck’s $11.5 billion acquisition of Acceleron Pharma, aced a phase 3 PAH trial last year. But J&J need not worry, because the Merck drug is designed as an add-on therapy for those who’re also on existing drugs such as Opsumit and Uptravi.
Elsewhere, J&J is fighting a group of generic contenders who intend to bring their copycats to the U.S. market early. Beginning in January, J&J’s Actelion filed patent infringement lawsuits against Sun Pharma, Alembic Pharma, MSN Laboratories and Apotex, all of which have filed FDA application for their versions of Opsumit.