Seven new drugs recommended by EMA/CHMP in December 2014, 82 overall in 2014

Seven new drugs have been recommended for marketing authorization at the December 2014 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This brings the total number of medicines recommended for approval by the CHMP in 2014 to 82.

The CHMP has recommended granting a conditional marketing authorisation for the orphan medicine Holoclar (ex-vivo) autologous corneal epithelial cells including stem cells, from Italy’s privately-held Chiesi Farmaceutici, for the treatment of moderate to severe limbal stem cell deficiency due to physical or chemical burns to the eyes in adults. Holoclar is the first advanced therapy medicine containing stem cells to be recommended for approval in the European Union.

The Committee also gave a positive opinion for Mysimba (naltrexone / bupropion) from US biopharma company Orexigen Therapeutics (Nasdaq: OREX), for weight management in adults who are obese, or those who are overweight and have one or more complications related to their weight. The medicine is recommended for use in addition to a reduced-calorie diet and physical activity.