Actelion's Opsumit approved by SwissMedic for PAH patients

Swiss biotech firm Actelion (SIX: ATLN) announced today that SwissMedic has approved Opsumit (macitentan) for pulmonary arterial hypertension (PAH) patients within Switzerland.

Opsumit is indicated to delay disease progression, including death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH.

Jean-Paul Clozel, chief executive of Actelion, said: “The SwissMedic approval, as one of the reference health authorities, is another positive step for Actelion and Opsumit in the global approval process. We are very proud that the convincing data from the SERAPHIN study and the translation into a label today, means that patients with PAH here in Switzerland can be treated with Opsumit. We will cooperate with the Swiss authorities to ensure availability for patients in due course.”