From their meeting in January, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
At this meeting there were seven recommendations for approvals of medicines, including one orphan medicine and one biosimilar medicine named Semglee (insulin glargine) for the treatment of diabetes.
The CHMP gave positive opinions for three medicines to treat type 2 diabetes and the CHMP confirmed its previous positive opinion, thus recommended the granting of a marketing authorisation for Lokelma (sodium zirconium cyclosilicate), for the treatment of hyperkalaemia.
The CHMP also published the findings from their re-examination of one negative recommendation adopted at the September 2017 meeting. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the change to the marketing authorisation.
The CHMP stated three recommendations on extensions of therapeutic indication and one negative opinion on a new medicine. Applications for initial marketing authorisation have been withdrawn for two medicines.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.