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.
Rekovelle (follitropin delta) was recommended for approval for controlled ovarian stimulation.
The Committee recommended granting a marketing authorisation for the orphan medicine SomaKit-TOC (edotreotide) for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumours.
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.
The Committee recommended extensions of therapeutic indications for Lucentis, Opdivo, Trisenox and Zebinix.
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.
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.
Applications for marketing authorisations for Ertapenem Hospira (ertapenem), Pemetrexed (as ditromethamine) Hospira (pemetrexed) and Zemfirza (cediranib) have been withdrawn.
The CHMP has elected a new vice-chair, Dr Harald Enzmann, for a three-year mandate. Dr Enzmann, a medical doctor by training, is currently Head of European and International Affairs at the German Federal Institute for Drugs and Medical Devices (BfArM) in Bonn, Germany. He has been a member of the CHMP since 2005.
From October 2016, the annexes to the CHMP meeting agenda and minutes will be made public. These annexes include information on pre-submission issues, post-authorisation procedures, renewals of marketing authorisations and type II variations. These documents will be available as part of the CHMP agenda and minutes on this page.
From October 2016, EMA is also publishing the agendas and minutes of the CHMP Organisational Matters (ORGAM) meeting. ORGAM meetings take place one week before the CHMP meetings and cover topics arising from EMA working parties and drafting groups, such as scientific guidelines, as well as topics related to the organisation of the CHMP. The first ORGAM agenda was published last week and is available on this page. The minutes will be published after the current month’s CHMP plenary meeting on the same page.
From this month EMA will no longer publish the following annexes as part of the CHMP highlights: ‘Opinions on safety variations’, ‘Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures’, ‘Guidelines and concept papers adopted’ and ‘Organisational matters’. This information will be included in the minutes of the CHMP meeting which are published approximately one month after the Committee meets.
The european medicines agency’s, medicinal products for human use (chmp), medicines
5.jpg)
