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) previously treated with crizotinib.

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. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data. 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 (congenital factor VIII deficiency). In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application 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.

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

The CHMP started a review of medicines for which studies have been conducted by Micro Therapeutic Research Labs at two sites 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.

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.

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 new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia has been withdrawn.