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Home Industry News Actelion receives CHMP recommendation for Opsumit

Actelion receives CHMP recommendation for Opsumit

28th October 2013

Actelion's new pulmonary arterial hypertension (PAH) therapy Opsumit has been recommended for European approval by the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency (EMA) committee has endorsed the therapy for use as a monotherapy or as part of a combination in the long-term treatment of PAH in adult patients of WHO Functional Class II to III.

In clinical trials, the drug has been shown to deliver benefits to patients with idiopathic and heritable PAH, PAH affecting those with connective tissue disorders and PAH associated with corrected simple congenital heart disease.

Opsumit has already been approved by the US Food and Drug Administration, with a final decision from the European Commission expected in the next two months.

Dr Jean-Paul Clozel, chief executive officer of Actelion, said: "Opsumit could transform the lives of many people living with PAH. This positive opinion stands testament to the efforts of our development teams and our ongoing commitment to patients living with PAH."

Earlier this month, the company published its financial results for the first nine months of 2013, during which it experienced a four percent year-on-year sales increase.ADNFCR-8000103-ID-801653964-ADNFCR

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