Posted by Michael Wonder on 15 Oct 2016
Highlights from CHMP October 2016 meeting
14 October 2016 - Eight medicines recommended for approval, including four orphan medicines.
The European Medicines Agency’s 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.
