EMA's CHMP Recommends Approvals for 11 Medicines

Published on: 

CHMP recommended 11 new medicines for approval, the most approval recommendations at a CHMP meeting thus far in 2013.

At its 16-19 September meeting, the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of two medicines for cancer: Kadcyla for the treatment of metastatic breast cancer and Xofigo for the treatment of castration-resistant prostate cancer.

The committee also gave positive recommendations for three medicines intended to treat neurological disorders: Abilify Maintena for the treatment of schizophrenia; Memantine Accord, a generic medicine, for the treatment of Alzheimer’s disease; and Levodopa Carbidopa Entacapone Sandoz, which was submitted as an informed consent application, for the treatment of adult patients with Parkinson’s disease.

The CHMP recommended that Vitekta should be granted marketing authorization for the treatment of HIV‑1 infection in adults who are infected with HIV‑1 without known mutations associated with resistance to elvitegravir.

Invokana received a positive opinion for marketing authorization for the treatment of type 2 diabetes mellitus.

NovoEight was recommended for marketing authorization for the treatment of haemophilia A; Relvar Ellipta received a positive opinion from the committee for the treatment of asthma and chronic obstructive pulmonary disorder.

The vaccine Fluenz Tetra was recommended for a marketing authorization for the prevention of influenza in children and adolescents 24 months to less than 18 years of age.


The committee recommended that Lidocaine/Prilocaine Plethora should be granted marketing authorization for the treatment of primary premature ejaculation in adult men.

In other decisions, the CHMP recommended an extension to the existing indications for Cimzia, Kineret, Votubia, and Yervoy.

The CHMP started a re-examination procedure for dihydroergotoxine, one of the medicines included in the Article-31 referral procedure on ergot derivatives. The other ergot derivatives in this referral are not included in this re-examination.

The Committee also started a re-examination procedure for metoclopramide-containing medicines.

Source: EMA