Highlights from the CHMP 19-22 June 2017 meeting

EMA

23 June 2017 - Eight medicines recommended for approval, including two medicines for chronic hepatitis C virus infection.

The European Medicines Agency’s CHMP recommended eight new medicines for approval at its June meeting.

The CHMP recommended granting marketing authorisations for Maviret (glecaprevir with pibrentasvir) and Vosevi (sofosbuvir with velpatasvir and voxilaprevir) for the treatment of chronic hepatitis C virus infection. Both medicines were reviewed under the EU’s accelerated assessment mechanism. For more information on these medicines, please see the joint press release in the grid below.

Two cancer medicines received a positive opinion from the CHMP: Kisqali (ribociclib) for the treatment of locally advanced or metastatic breast cancer and Fotivda (tivozanib) for the treatment of advanced renal cell carcinoma.

Mavenclad (cladribine) received a positive opinion for the treatment of relapsing forms of multiple sclerosis.

Read EMA press release

Michael Wonder

Posted by:

Michael Wonder