Actelion’s Opsumit approved for PAH by FDA

In Regulation & Government by Tim Peplow

actelion (patrik tschudin)

Opsumit, Actelion’s follow-up to Tracleer, has been approved by FDA for the treatment of pulmonary arterial hypertension (PAH).

Actelion’s blockbuster Tracleer (bosentan), which recorded sales of 1.5 billion francs in 2012, is due to go off-patent in 2015, so the approval of Opsumit (macitentan) will fill the gap for the Swiss biotech company.

A key difference between new Opsumit and old Tracleer is that the new drug does not require mandatory liver testing.

PAH is a rare disease characterized by high blood pressure in the pulmonary arteries leading to the lungs from the heart. Opsumit, an endothelin receptor antagonist, relaxes the pulmonary arteries. The orphan drug has been shown to be effective in delaying the progression of the disease. The 742-patient Phase III SERAPHIN trial showed that Opsumit was capable of reducing risk of a morbidity and mortality event by 45% in patients with PAH in the 10mg dose group.

Opsumit also has orphan designation for treatment of idiopathic pulmonary fibrosis (EU, FDA).

Bayer’s Adempas (riociguat) was approved earlier this month for PAH, and the drug will also have competition from Gilead/GSK’s Letairis/Volibris (ambrisentan).

Read more at Reuters >

Next: 4 orphan drugs to watch out for

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