Switzerland-based Actelion recently announced that the US Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for macitentan. Actelion is looking to get macitentan approved in the US as a treatment for patients suffering from pulmonary arterial hypertension (PAH).
Actelion had submitted the NDA in October 2012. The US regulatory body is expected to review the application for 12 months from the date of submission, which means a response should be out by the fourth quarter of 2013.
The company conducted a long-term, event-driven phase III outcome study, SERAPHIN, with macitentan. Results from the study revealed that treatment with macitentan (10mg once daily) reduced the risk of morbidity and mortality by 45% compared to placebo. The risk was reduced by 30% in PAH patients treated with the 3 mg dosage of the drug.
We note that in November this year the European Medicines Agency (EMA) accepted Actelion’s Marketing Authorisation Application (MAA) for macitentan.
Actelion currently has three marketed products, Tracleer, Ventavis and Veletri, for the treatment of PAH. We remind investors that during the first nine months of 2012 the company reported a decline in sales of Tracleer and Ventavis from the year-ago period. Veletri, launched in 2010, however did very well during this period.
Actelion currently competes with players such as Gilead Sciences (GILD - Free Report) and United Therapeutics (UTHR - Free Report) in the PAH space. We believe that if macitentan is cleared in the US and the EU, Actelion’s position in the PAH market would be strengthened further.
Actelion carries a Zacks #1 Rank (Strong Buy) in the short run whereas United Therapeutics carries a Zacks #2 Rank (Buy).