Seven new medicines recommended for approval in December 2014, 82 overall in 2014

Seven new medicines have been recommended for marketing authorisation at the December 2014 meeting of the 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 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. For more information please see the press release in the grid below.

The Committee also gave a positive opinion for Mysimba (naltrexone / bupropion) 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. For more information please see the press release in the grid below.

Xadago (safinamide) received a positive opinion for the treatment of Parkinson’s disease.

Xydalba (dalbavancin) received a positive opinion for the treatment of skin and skin structure infections. The orphan medicine Quinsair (levofloxacin) has been recommended for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.

The CHMP granted a positive opinion for the informed consent application Tasermity (sevelamer hydrochloride) for the control of hyperphosphataemia in adults receiving dialysis. In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure.

The generic medicine Clopidogrel ratiopharm (clopidogrel) received a positive opinion for the prevention of myocardial infarction, ischaemic stroke, peripheral arterial disease and acute coronary syndrome, as well as the prevention of atherothrombotic and thromboembolic events in atrial fibrillation.

Four recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for four medicines: Revlimid, TresibaVelcade and Xiapex.

Update on GVK Biosciences review

The review procedure for GVK Biosciences is ongoing. In line with the published timetable, the CHMP is expected to give a recommendation on this issue following its January 2015 meeting.

 

Posted on the EMA website on 19 December 2014