EMA’s CHMP approves recommends eight products for approval
The EMA’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 authorization 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 authorization for Venclyxto (venetoclax) for the treatment of adults with chronic lymphocytic leukemia (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 authorization 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.
Four recommendations on extensions of therapeutic indications
The Committee recommended extensions of 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. For more information, please see the public health communication in the grid below.
Applications for marketing authorizations for Ertapenem Hospira (ertapenem), Pemetrexed (as ditromethamine), Hospira (pemetrexed) and Zemfirza (cediranib) have been withdrawn.