EMA Recommends Seven New Medicines for Marketing Authorization

At the European Medicine’s Agency Committee for Medicinal Products for Human Use (CHMP) meeting, held Dec. 15­–18, 2014, it was announced that seven new medicines would be recommended for marketing authorization in Europe, bringing the total of CHMP-recommended medicines in 2014 to 82:

• Holoclar-An orphan medicine that is the first advanced therapy containing stem cells recommended for approval in the EU, Holoclar is used in the treatment of moderate to severe limbal stem-cell deficiency due to physical or chemical burns to the eyes in adults.

• Mysimba (naltrexone/bupropion)-Used for weight management in obese adults, or those that are experiencing complications due to their weight.

• Xadago (safinamide)-Used in the treatment of Parkinson’s disease.

• Xydalba (dalbavancin)-Used in the treatment of skin and skin structure infections.

• Quinsair (levofloxacin)-Used in the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adults with cystic fibrosis.

• Tasermity (sevelamer hydrochloride)-Used in the treatment of hyperphosphataemia in adults receiving dialysis.

• Clopidogrel ratiopharm (clopidogrel)-Used for the prevention of myocardial infarction, ischaemic stroke, peripheral arterial disease, acute coronary syndrome, and in the prevention of atherothrombotic and thromboembolic events in atrial fibrillation.

In addition to the seven marketing recommendations, there were four medicines recommended for extensions of indication: Revlimid, Tresiba, Velcade, and Xiapex.

Source: EMA