Good news flowed in at
) with the Therapeutic Goods Administration of Australia
approving Opsumit 10 mg for the treatment of pulmonary
arterial hypertension (PAH).
We note that Opsumit was approved by the U.S. Food and Drug
Administration on Oct 18, 2013. Health Canada and EU also
approved this drug in Nov 2013 and Dec 2013 respectively.
Opsumit is indicated for the treatment of idiopathic and
heritable PAH as well as PAH associated with connective tissue
disease and congenital heart disease. Opsumit is used to treat
patients with WHO Functional class II, III or IV symptoms.
Actelion believes that Opsumit can improve long-term clinical
outcomes both in treatment naive patients and those on a
The approval 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.
Actelion is also evaluating Opsumit for additional
indications. Opsumit is being evaluated for the treatment of
glioblastoma (phase I). It is also being evaluated in a pivotal
phase III DUAL program in patients suffering from digital ulcers
associated with systemic sclerosis. The independent Data
Monitoring Committee (DMC) has recommended the termination of the
phase III DUAL-2 study as it feels a positive primary outcome
measure is not likely to result from additional data. However,
the DUAL-1 study will continue as planned.
In Australia, Opsumit is the first and only PAH drug to have
proved its long-term efficacy in PAH patients. The approval of
this drug has strengthened Actelion's cardiovascular
Interesting candidates in Actelion's pipeline include
selexipag (PAH) and Cadazolid (clostridium difficile associated
diarrhea). Both candidates are undergoing phase III studies. The
final results from the study on selexipag are expected in mid
Actelion carries a Zacks Rank #1 (Strong Buy). Investors may
also consider companies like
Lannett Company, Inc.
Forest Laboratories Inc.
), all of which carry a comparable Zacks Rank #1.
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