Actelion Ltd has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for its pulmonary arterial hypertension (PAH) drug, Opsumit.
Actelion is looking to get Opsumit approved in the EU as monotherapy or in combination, for the long-term treatment of PAH in adults of WHO functional class II to III.
A final decision on Opsumit should be out in two months. With the CHMP adopting a positive opinion, we expect Opsumit to gain EU approval. It has also filed for approval in other regions.
The positive opinion was based on data from the SERAPHIN study. Results from the SERAPHIN study showed that the risk of a morbidity/mortality event was cut by 45% in patients who were administered Opsumit compared to those on placebo. The study also showed a reduction in the risk of PAH related hospitalization and death by 50% as compared to placebo.
A few days back, the U.S. Food and Drug Administration approved Opsumit 10 mg once daily for the treatment of PAH WHO Group I. Actelion will launch Opsumit in the U.S. in Nov 2013.
Opsumit is also being evaluated in a pivotal phase III program in patients suffering from digital ulcers associated with systemic sclerosis. Results from this study are expected in the first half of 2014. In addition, Opsumit is being evaluated for the treatment of glioblastoma (phase I).
We believe the Opsumit approval in the U.S. will strengthen Actelion’s cardiovascular portfolio. However, the PAH market looks extremely competitive with the presence of Bayer’s (BAYRY - Free Report) Adempas, Pfizer Inc.’s (PFE - Free Report) Revatio and Gilead Sciences Inc.’s (GILD - Free Report) Letairis.
Actelion carries a Zacks Rank #1 (Strong Buy) while Bayer carries a Zacks Rank #2 (Buy).