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The Committee for Medicinal Products for Human Use (CHMP) has 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. UltibroBreezhaler and XoternaBreezhaler 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
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, Stelaraand 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.