CHMP News – January 2015


Seven new medicines have been recommended for approval at the January 2015 meeting of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended the following:

  • 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.
  • Granting a marketing authorisation for Orbactiv (oritavancin) and Sivestro (tedizolid phosphate).
  • Granting a marketing authorisation for Dutrebis (lamivudine/raltegravir) as a new treatment option for human immunodeficiency virus (HIV-1).
  • Granting a marketing authorisation for Ikervis (ciclosporin) for the treatment of severe keratitis, an eye condition in which the cornea becomes inflamed.
  • Granting a marketing authorisation for Kengrexal (cangrelor) for the reduction of thrombotic cardiovascular events and Raplixa (human fibrinogen/human thrombin) as a supportive tretment where standard surgical techniques are insufficient for the improvement of haemostasis.

Five recommendations on extensions of therapeutic indication

The CHMP recommended extensions of indications for Abraxane, Aloxi, Eylea, Jakavi and Prevenar 13

Outcome of GVK Biosciences review

The CHMP has recommended that a number of medicines for which authorisation in the EU was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India, should be temporarily suspended.

Here you may find more information on this review.

More on the CHMP January 2015 meeting may be found on the EMA webpages, or here.