Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 October 2014
Six new medicines recommended 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.
The European Medicines Agency 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.
During the evaluation of Scenesse, the CHMP invited patients to share their experience of living with this condition. This is the first time that patients have been involved in CHMP discussions on the benefits and risks of a medicine. For more information please see the press release in the grid below.
The CHMP also gave a positive opinion for 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. For more information please see the press release in the grid below.
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.
The CHMP granted positive opinions for two informed consent applications: Duloxetine Lilly (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder, and Paliperidone Janssen (paliperidone) for the treatment of schizophrenia. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.
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 in the grid below.
Agenda and minutes
The agenda of the October 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the November CHMP meeting.
Key figures from the October 2014 CHMP meeting are represented in the graphic below.
* This figure includes a withdrawn application adopted by written procedure after the July CHMP meeting.
Positive recommendations on new medicines
|Name of medicine||Duavive|
|International non-proprietary name (INN)||estrogens conjugated / bazedoxifene|
|Marketing-authorisation applicant||Pfizer Limited|
|Therapeutic indication||Treatment of oestrogen deficiency syndrome|
|More information||Summary of opinion for Duavive|
|Name of medicine||Lynparza|
|Marketing-authorisation applicant||AstraZeneca AB|
|Therapeutic indication||Treatment of ovarian cancer|
|More information||Summary of opinion for Lynparza|
|Press release: Lynparza recommended for approval in ovarian cancer|
|Name of medicine||Rixubis|
|Marketing-authorisation applicant||Baxter Innovations GmbH|
|Therapeutic indication||Treatment and prophylaxis of bleeding in patients with haemophilia B|
|More information||Summary of opinion for Rixubis|
|Name of medicine||Scenesse|
|Marketing-authorisation applicant||Clinuvel (UK) Limited|
|Therapeutic indication||Treatment of phototoxicity|
|More information||Summary of opinion for Scenesse|
|Press release: Scenesse recommended for rare disease that causes intolerance to sunlight|
Positive recommendations on new informed consent applications
|Name of medicine||Duloxetine Lilly|
|Marketing-authorisation applicant||Eli Lilly Nederland B.V.|
|Therapeutic indication||Treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder|
|More information||Summary of opinion for Duloxetine Lilly|
|Name of medicine||Paliperidone Janssen|
|Marketing-authorisation applicant||Janssen-Cilag International NV|
|Therapeutic indication||Treatment of schizophrenia|
|More information||Summary of opinion for Paliperidone Janssen|
Positive recommendation on extension of therapeutic indication
|Name of medicine||Xtandi|
|Marketing-authorisation holder||Astellas Pharma Europe B.V.|
|More information||Summary of opinion for Xtandi|
|Name of medicine||Iclusig|
|Marketing-authorisation holder||Ariad Pharma Ltd|
|More information||European Medicines Agency recommends further measures to minimise risk of blood vessel blockage with Iclusig|
|Name of medicine||Polymyxin-containing medicines|
|INN||colistin, colistimethate sodium|
European Medicines Agency completes review of polymyxin-based medicines
Outcome of arbitration procedure
|Name of medicine||Oxynal, Targin and associated names|
|INN||oxycodone / naloxone|
|Marketing-authorisation holder||Mundipharma GmbH|
|More information||Questions and answers on Oxynal, Targin and associated names|
Outcome of harmonisation procedure
|Name of medicine||Plendil|
|Marketing-authorisation holder||Astra Zeneca group of companies and associated companies|
|More information||Questions and answers on Plendil and associated names|