The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended eight new medicines for approval, including four orphan medicines.
The CHMP recommended the following:
• Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (also known as primary bile cirrhosis). Ocaliva is an orphan-designated medicine
• Venclyxto (venetoclax) for the treatment of adults with chronic lymphocytic leukaemia. Venclyxto has an orphan designation
• Cystadrops (mercaptamine) for the treatment of corneal cystine crystal deposits in patients with cystinosis. Cystadrops has an orphan designation
• Rekovelle (follitropin delta) for controlled ovarian stimulation
• SomaKit-TOC (edotreotide) for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumours. Edotreotide has an orphan designation.
Also, 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 medicines are intended for the treatment of HIV infection in adults.
Additionally, four recommendations were made on extensions of therapeutic indications for Lucentis, Opdivo, Trisenox and Zebinix, while the CHMP also 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.