Medicinal Products

Meeting highlights from the CHMP meeting in December 2016


Seven medicines recommended for authorisation, 81 overall in 2016

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorisation at its December 2016 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2016 to 81.

The CHMP recommended granting a marketing authorisation to Olumiant (baricitinib) for the treatment of moderate to severe active rheumatoid arthritis.

The CHMP recommended granting a conditional marketing authorisation for Alecensa (alectinib) for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Lifmior (etanercept) received a positive recommendation from the Committee for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis.

A biosimilar medicine, Truxima (rituximab), received a positive opinion from the CHMP for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

One hybrid medicine, Ledaga (chormethine), received a positive opinion for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma. Ledaga has an orphan designation.

A generic medicine, Pregabalin Zentiva k.s (pregabalin), received a positive opinion from the Committee for the treatment of epilepsy, neuropathic pain and generalised anxiety disorder.

The CHMP also granted a positive opinion for the informed consent application for Vihuma (simoctocog alfa) for the prevention and treatment of bleeding in patients with haemophilia A.

Positive opinion on Zinplava adopted by written procedure

In addition to the positive opinions for the seven new medicines adopted at the December 2016 meeting, the CHMP recommended granting a marketing authorisation for Zinplava (bezlotoxumab) to prevent the recurrence of Clostridium difficile infection via written procedure on 22 November 2016.

Nine recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Ameluz, Cinryze, Ilaris, Jardiance, Jentadueto, Keytruda, Tivicay, Trajenta and Votubia.

Start of referral related to studies conducted by the Micro Therapeutics Research Labs, India

The CHMP started a review of medicines for which studies have been conducted by Micro Therapeutic Research Labs at two sites, Chennai and Coimbatore, in India. This follows a good clinical practice inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the European Union.

More information is available on HALMED's website.

Recommendations for screening for hepatitis B before treatment with direct-acting antivirals for hepatitis C

The CHMP confirmed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C. Patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines. These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals.

More information is available on HALMED's website.

Withdrawals of applications

Applications for marketing authorisations for Cavoley (pegfilgrastim), Efgratin (pegfilgrastim), Graspa (eryaspase) and Kepnetic (aceneuramic acid) have been withdrawn. A request to extend the indication of Arzerra (ofatumumab) to be used in a combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia has also been withdrawn.

More information on CHMP's December 2016 meeting can be found on EMA's website.