Seven new medicines recommended for approval

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.

Five recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Abraxane, Aloxi, EyleaJakavi and Prevenar 13.

Outcome of GVK Biosciences review

The CHMP concluded that a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs. The CHMP’s recommendation is based on findings from an inspection that raised concerns over how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders.

For more information on the review, and for the list of affected medicines, please see the public health communication in the grid below.


Posted on the EMA website on 23 January 2015