Medicinal Products

Meeting highlights from the CHMP meeting in October 2016


Eight medicines recommended for approval, including four orphan medicines

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its October meeting.

The CHMP recommended granting a conditional marketing authorisation for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (also known as primary bile cirrhosis). Ocaliva is an orphan-designated medicine.

The Committee recommended granting a conditional marketing authorisation for Venclyxto (venetoclax) for the treatment of adults with chronic lymphocytic leukaemia (CLL). Venclyxto has an orphan designation.

Cystadrops (mercaptamine) was recommended for approval by the CHMP for the treatment of corneal cystine crystal deposits in patients with cystinosis. Cystadrops has an orphan designation.

The Committee recommended granting a marketing authorisation for the orphan medicine SomaKit-TOC (edotreotide) for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumours.

Rekovelle (follitropin delta) was recommended for approval for controlled ovarian stimulation.

Three generic medicines were recommended for approval: Emtricitabine / Tenofovir disoproxil Mylan (emtricitabine / tenofovir disoproxil), Emtricitabine / Tenofovir disoproxil Krka (emtricitabine / tenofovir disoproxil) and Tenofovir disoproxil Mylan (tenofovir disoproxil). These three medicines are intended for the treatment of HIV infection in adults.

Four recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Lucentis, Opdivo, Trisenox and Zebinix.

Outcome of review of metformin-containing medicines

The CHMP has concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function for the treatment of type 2 diabetes. The recommendations are the result of a review by the Committee following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function.

Please see EMA's website for more information.

CHMP recommends measures to ensure safe use of Keppra oral solution

Several measures have been put in place to ensure that the correct dosing syringe is used to measure Keppra (levetiracetam) oral solution, and thus avoid medication errors. Keppra is a medicine used to treat epilepsy in adults and children.

Please see EMA's website for more information.

Withdrawals of applications

Applications for marketing authorisations for Ertapenem Hospira (ertapenem), Pemetrexed (as ditromethamine) Hospira (pemetrexed) and Zemfirza (cediranib) have been withdrawn.

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