Posted by Michael Wonder on 28 Jul 2018
Highlights from the CHMP 23-26 July 2018 meeting
27 July 2018 - Sixteen medicines recommended for approval, including two orphans
The EMA CHMP recommended 16 medicines for approval, including two orphan medicines, at its July 2018 meeting.
The Committee recommended granting a marketing authorisation for Onpattro (patisiran), for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (a condition in which the peripheral nerves are damaged). This medicine was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest.
The CHMP recommended granting two new paediatric-use marketing authorisations, for Kigabeq (vigabatrin), for the treatment of infantile spasms (West's syndrome) and resistant partial epilepsy, and Slenyto (melatonin), for the treatment of insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome.
Symkevi (tezacaftor with ivacaftor) received a positive opinion for the treatment of cystic fibrosis. Symkevi was designated as an orphan medicine during its development.
