Highlights from the CHMP 23-26 May 2016 meeting

27 May 2016 - Six medicines, including two combination therapies for chronic hepatitis C, recommended for approval.

The European Medicines Agency’s CHMP recommended six medicines for approval at its May meeting.

The CHMP recommended granting marketing authorisations in the European Union for two new combination therapies to treat chronic (long-term) hepatitis C, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir). For more information please see the press release in the grid below.

Qtern (saxagliptin / dapagliflozin) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus.

Three generic medicines received a positive opinion from the Committee: Bortezomib Hospira (bortezomib) and Bortezomib Sun (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma, and Pemetrexed Fresenius Kabi (pemetrexed) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002535.jsp&mid=WC0b01ac058004d5c1

Michael Wonder

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Michael Wonder