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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2013

London, UK (July 26, 2013) – This page provides an overview of the opinions adopted at the July 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. At its July meeting, the CHMP welcomed Ivana Mikačić as the Croatian member of the Committee following the accession of Croatia to the European Union on 1 July 2013. Ana Dugonjić has been appointed as the Croatian alternate. This addition brings the total number of CHMP members to 33.

Eight new medicines recommended for approval

The CHMP recommended the approval of Giotrif for the treatment of lung cancer.

The CHMP also recommended that Incresync, Vipdomet and Vipidia should be granted marketing authorisations for the treatment of type 2 diabetes.

Ultibro Breezhaler and Xoterna Breezhaler received positive opinions from the Committee for the treatment of chronic obstructive pulmonary disease (COPD).

The Committee recommended that Tybost should be granted a marketing authorisation for the treatment of human immunodeficiency virus-1 (HIV-1) infection in combination with protease inhibitors atazanavir and darunavir.

The Committee also gave a positive recommendation for the approval of Grastofil, a biosimilar medicine for the treatment of neutropenia.

Negative opinion for Delamanid

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The Committee adopted a negative opinion for Delamanid which was intended for the treatment of multi-drug resistant tuberculosis.

Seven recommendations on extensions of therapeutic indications

The CHMP recommended extensions to the existing indications for Eylea, Ilaris, Prezista, Revolade, Simponi, Stelara and Zonegran.

Re-examination of two initial recommendations for marketing authorisation

The CHMP adopted a positive re-examination opinion for Defitelio, for the treatment of severe hepatic veno-occlusive disease (VOD) in patients undergoing blood stem-cell transplantation.

It also adopted a final negative opinion following the re-examination of Xeljanz which was intended for the treatment of moderate to severe active rheumatoid arthritis.

Investigation on GLP-1 based diabetes therapies concluded

The CHMP has finalised a review of GLP-1 based diabetes therapies. The Committee concluded that available data do not confirm recent concerns over an increased pancreatic cancer risk with these medicines. For more information, please see the press release on the Agency’s website.

Outcome of two further safety reviews

In addition to the safety review on GLP-1-based diabetes therapies, the Committee also issued recommendations on ketoconazole-containing products for oral use and metoclopramide-containing products.

More information on these and all other outcomes of this month’s meeting are available on the Agency’s website at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/07/news_detail_001851.jsp&mid=WC0b01ac058004d5c1

European Medicines Agency, 26.07.2013 (tB).