Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2014

EMA

The CHMP has recommended five new medicines for approval at its July 2014 meeting.

The CHMP has recommended granting marketing authorisations for two new medicines for the treatment of various rare cancers of the blood, Imbruvica (ibrutinib) andZydelig (idelalisib). Please see the press release in the grid below for more information.

Granting a marketing authorisation to Xultophy (insulin degludec/liraglutide) for the treatment of diabetes mellitus has also been recommended.

The CHMP recommended granting a marketing authorisation for Accofil (filgrastim), abiosimilar medicine intended for the treatment of neutropenia.

The generic medicine Busulfan Fresenius Kabi (busulfan) was also recommended for authorisation for conditioning treatment prior to conventional haematopoietic progenitor cell transplantation.

The CHMP has also recommended extensions of therapeutic indications for seven medicines: Baraclude, Busilvex, Ecalta, Humira, Ozurdex, RoActemra and Xgeva.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/07/news_detail_002142.jsp&mid=WC0b01ac058004d5c1

Michael Wonder

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Michael Wonder

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