News and Educations

CHMP News – October 2014


CHMP recommended six new medicines for approval

Six new medicines have been recommended for approval at the October meeting of the Committee for Medicinal Products for Human Use (CHMP), two of which are for orphan conditions with the following recommendations:

  • The CHMP has recommended granting a marketing authorisation under exceptional circumstances for Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria (EPP), a rare genetic disease which causes intolerance to light. Scenesse is the first medicine for patients with this condition. This type of authorisation is granted to medicines where comprehensive data on the medicine cannot be collected, for example, because the condition is too rare, or because the collection of full information is not possible or is unethical.
  • Lynparza (olaparib), a first-in-class medicine for the treatment of women with a subtype of ovarian cancer for which there are limited treatment options. Lynparza has an orphan designation.
  • Duavive (conjugated oestrogens / bazedoxifene) was recommended by the CHMP as a new treatment option for oestrogen deficiency.
  • Rixubis (nonacog gamma) received a positive opinion for the treatment and prophylaxis of bleeding in patients with haemophilia B.
  • Duloxetine Lilly (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder
  • Paliperidone Janssen (paliperidone) for the treatment of schizophrenia. Recommendation on extension of therapeutic indication

The Committee recommended an extension of indication for Xtandi.

Outcome of two safety reviews

The CHMP has concluded its review of the benefits and risks of Iclusig (ponatinib), a medicine for the treatment of leukaemia, and has recommended strengthened warnings in the product information aimed at minimising the risk of blood clots and blockages in the arteries.

The Committee also reviewed the safety and efficacy of medicines containing the antibiotics colistin or colistimethate sodium (known as polymyxins) and recommended changes to the product information of products for injection or inhalation to ensure their safe and effective use in the treatment of serious infections that are resistant to standard antibiotics.

More information on these reviews, and all other outcomes of the CHMP October 2014 meeting, is available on the EMA webpages or here.