Posted by Michael Wonder on 01 Feb 2020
Highlights from the CHMP 27-30 January 2020 meeting
31 January 2020 - Fifteen new medicines recommended for approval.
EMA’s human medicines committee (CHMP) recommended fifteen medicines for approval at its January 2020 meeting.
The Committee recommended granting a marketing authorisation for Givlaari* (givosiran), the first treatment for acute hepatic porphyria in adults and adolescents aged 12 years and older. Acute hepatic porphyria is a rare life-threatening genetic condition that causes attacks of severe abdominal pain, vomiting and nervous system disorders, such as seizures, depression and anxiety.
The CHMP adopted a positive opinion for Rybelsus (semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise.
