The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued its latest list of opinions which has seen the agency back Johnson & Johnson’s new HIV drug Intelence.
The CHMP has recommended the granting of a marketing authorisation, for Intelence (etravirine), from J&J’s Janssen-Cilag unit, for use in combination with a boosted protease inhibitor and other antiretroviral medicines for the treatment of HIV-1 infection in treatment-experienced adults. The agency also backed UCB’s Vimpat (lacosamide) for use as adjunctive therapy in the treatment
of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 and older.
Another drug which got the thumbs-up from the CHMP was Orexo/ProStrakan’s Abstral/Rapinyl (fentanyl) for breakthrough cancer pain and the Swedish firm’s chief executive Torbjorn Bjerke said the approval “is a fantastic achievement for Orexo and our ability to become a profitable pharmaceutical company”.
The EMEA also gave a positive opinion to Eli Lilly to extend the indication on Cymbalta (duloxetine) to include the treatment of generalised anxiety disorder, while Actelion’s Tracleer (bosentan) will have its label expanded to include the fact that some improvements have also been shown in patients with pulmonary arterial hypertension functional class II.
The CHMP has also issued a positive opinion to Krka’s Oprymea, a generic version of Boehringer Ingelheim’s Sifrol (pramipexole), for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.
