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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013

London (September 20, 2013) – This page provides an overview of the opinions adopted at the September 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. This month, the Committee recommended 11 new medicines for approval – the most medicines recommended for approval at a CHMP meeting so far in 2013.

Eleven new medicines recommended for approval

The CHMP 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 a so-called informed consent application,for the treatment of adult patients with Parkinson’s disease.

The CHMP also recommended that Vitekta should be granted marketing authorisation for the treatment of human immunodeficiency virus‑1 (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 authorisation for the treatment of type 2 diabetes mellitus.

NovoEight was recommended for marketing authorisation for the treatment of haemophilia A and Relvar Ellipta received a positive opinion from the Committee for the treatment of asthma and chronic obstructive pulmonary disorder (COPD).

The vaccine Fluenz Tetra was recommended for a marketing authorisation 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 authorisation for the treatment of primary premature ejaculation in adult men.

Four recommendations on extensions of therapeutic indications

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

Two re-examination procedures for referral opinions started

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.

More information on these, and all other outcomes of this month’s meeting, are available in the table below.

CHMP welcomes new members

At the September CHMP, Daniel Brasseur, former Chair of the Paediatric Committee (PDCO), replaced Pieter Neels as the Belgian CHMP member. Before joining the PDCO, Dr Brasseur was chair of the CHMP. Pieter de Graeff replaced Barbara van Zwieten-Boot as the new CHMP member from the Netherlands, and Greg Markey became the new CHMP member from the UK, replacing Ian Hudson, who was recently appointed Chief Executive of the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).

Positive recommendations on new medicines

Positive recommendation on new informed-consent application

Positive recommendation on new generic medicine 

Positive recommendations on extensions of therapeutic indications   

Recommendations for new contraindications  

Outcome of arbitration procedure

Re-examinations started 

Other updates

European Medicines Agency (EMA), 20.09.2013 (tB).