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 Mikacic as the Croatian member of the Committee following the accession of Croatia to the European Union on 1 July 2013. Ana Dugonjic 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 medicinefor the treatment of neutropenia.


Negative opinion for Delamanid

  • 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 in the grid below.


Outcome of two further safety reviews

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


More information on these and all other outcomes of this month’s meeting are available in the link below.


Posted on the EMA website on 26 July 2013