Seven new medicines have been recommended for approval at the January 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).
The Committee has recommended granting a marketing authorisation for Saxenda(liraglutide) 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.
The CHMP also gave positive opinions for Orbactiv (oritavancin) and Sivextro (tedizolid phosphate), two antibiotics for the treatment of acute bacterial skin and skin structure infections.
Dutrebis (lamivudine / raltegravir) was recommended by the Committee as a new treatment option for human immunodeficiency virus (HIV-1).
Ikervis (ciclosporin) was recommended for the treatment of severe keratitis, an eye condition in which the cornea becomes inflamed.
Kengrexal (cangrelor) received a positive opinion from the Committee for the reduction of thrombotic cardiovascular events and Raplixa (human fibrinogen / human thrombin)received a positive opinion as a supportive treatment where standard surgical techniques are insufficient for the improvement of haemostasis.
The Committee also recommended extensions of indications for Abraxane, Aloxi, Eylea, Jakavi and Prevenar 13.
For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/01/news_detail_002250.jsp&mid=WC0b01ac058004d5c1