LONDON (Reuters) - European regulators said on Friday they had recommended approval of Roche’s drug Gazyvaro, or obinutuzumab, for patients with chronic lymphocytic leukemia, boosting the Swiss group’s line-up of new cancer treatments.
The new medicine is an improved follow-on medicine to Roche’s $7 billion-a-year Rituxan, or MabThera, and Roche is hoping to switch as many patients as possible to the newer product before Rituxan faces competition from cheaper copies.
The European Medicines Agency also gave a green light to Biogen Idec’s Plegridy for multiple sclerosis and a recommendation for conditional approval to PTC Therapeutics’ Translarna for Duchenne muscular dystrophy.
Shares in PTC soared on the green light.
Novartis received a mixed bag of news, with its Alcon eyecare unit winning a recommendation for Simbrinza, a treatment for open-angle glaucoma or ocular hypertension, but heart treatment serelaxin was rebuffed once again following further re-examination by EU experts.
Recommendations for marketing approval by the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
Reporting by Ben Hirschler; Editing by Paul Sandle, Greg Mahlich