Positive EMA/CHMP opinions for Actelion and Lundbeck

At its October month-end meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a number of recommendations, including positive opinions for Opsumit and Brintellix.

The CHMP issued a positive opinion for the use of Swiss biotech firm Actelion’s (SIX: ATLN) Opsumit (macitentan) 10mg for the treatment of pulmonary arterial hypertension (PAH). The product is expected to replace Actelion’s leading PAH drug, Tracleer (bosentan), which is soon facing patent expirations

The CHMP recommended that the European Commission approves Opsumit, as monotherapy or in combination, for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.