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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 2013

London, UK (November 22, 2013) – This press release provides an overview of the opinions adopted at the November 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Seven medicines recommended for approval

The CHMP recommended granting a marketing authorisation for Sovaldi (sofosbuvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C in adults. Please see press release for more information.

The CHMP recommended the approval of Tivicay in combination with other anti-retroviral medicines for the treatment of adults and adolescents over 12 years of age infected with human immunodeficiency virus (HIV). Please see press release for more information.

The CHMP recommended marketing authorisations for two tuberculosis medicines. One is Deltyba (delamanid), which is recommended for the treatment of pulmonary infections due to multidrug-resistant tuberculosis; the other is Para-aminosalicylic acid Lucane, recommended for the treatment of multidrug-resistant tuberculosis. Both are orphan medicines. Please see press release for more information.

The Committee also recommended the granting of a marketing authorisation for Xigduo for the treatment of type 2 diabetes.

The Committee gave a positive recommendation for Cholic Acid FGK for the treatment of inborn errors of primary bile acid synthesis. Cholic Acid FGK is an orphan medicine.

The generic medicine Zoledronic Acid Accord also received a positive opinion for use in the prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.

Update of previous Tecfidera opinion

The CHMP has updated its previous opinion and agreed that dymethil fumarate in Tecfidera is qualified as a new active substance. More information will be made available in a summary of opinion shortly.

Negative opinion for Masican

The Committee adopted a negative opinion for the orphan medicine Masican, which was intended for the treatment of gastrointestinal stromal tumour.

Three recommendations on extensions of therapeutic indications

The CHMP recommended adding the treatment of patients with metastatic pancreatic cancer to the approved indications for Abraxane. Please see press release for more details.

The Committee also recommended extensions of indications for Pradaxa and Velcade.

New compassionate-use programme

The CHMP has given an opinion on the use of daclatasvir in combination with sofosbuvir in the treatment of chronic (long-term) hepatitis C virus infection, in a compassionate-use programme. More information is available in a separate press release.

Outcome of combined hormonal contraceptives safety review

The CHMP has completed its review of combined hormonal contraceptives (CHCs). The CHMP endorsed the October 2013 recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small. The review reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.

Outcome of safety review of thiocolchicoside-containing medicines      

In addition to the safety review on CHCs, the Committee also issued recommendations on thiocolchicoside-containing medicines.

Update on Iclusig

The CHMP made a number of recommendations intended to minimise the risk of blood clots obstructing the arteries and veins in patients taking the leukaemia medicine Iclusig. The recommendations follow a review of data from two ongoing clinical trials indicating that blood clots were occurring at a higher rate than was observed at the time of the medicine’s initial authorisation.

More information on these and all other outcomes of this month’s meeting are available on the Agency’s website at:

• http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/11/news_detail_001963.jsp&mid=WC0b01ac058004d5c1

European Medicines Agency, 22.11.2013. (tB)