EMA Highlights: Green light for new medicines

by Gary Finnegan: Seven new medicines have approved at the January meeting of the Committee for Medicinal Products for Human Use (CHMP) – the European Medicines Agency’s influential evaluation committee.

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.

The CHMP also gave positive opinions for the following products:

–         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

–         Raplixa (human fibrinogen / human thrombin) received a positive opinion as a supportive treatment where standard surgical techniques are insufficient for the improvement of haemostasis.

Five extensions of therapeutic indication were also approved. The Committee recommended extensions of indications for Abraxane, Aloxi, Eylea, Jakavi and Prevenar 13.