) announced the launch of Opsumit 10 mg in the U.S. for the
treatment of patients suffering from pulmonary arterial
hypertension (PAH WHO Group I) to delay disease progression.
Disease progression includes events like death, commencement of
intravenous or subcutaneous prostanoids or clinical worsening of
The SERAPHIN study established the effectiveness of Opsumit in
PAH patients with predominantly WHO Functional Class II-III
symptoms treated for an average of 2 years. Opsumit was approved
by the U.S. Food and Drug Administration on Oct 18, 2013
The approval of the drug in the EU for the PAH indication is
also on track. Last month, Actelion received a positive opinion
from the Committee for Medicinal Products for Human Use (CHMP)
for 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 by year end. It has also filed
for approval in other regions.
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 launch of Opsumit in the U.S. will strengthen
Actelion's cardiovascular portfolio. Opsumit is the first drug to
have proved its efficacy in delaying disease progression over the
long term in PAH patients. 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 is a
Zacks #2 (Buy) Ranked stock.
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