) 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
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
) Revatio and
Gilead Sciences Inc.
Actelion carries a Zacks Rank #1 (Strong Buy) while Bayer
carries a Zacks Rank #2 (Buy).
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