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.

CHMP statistics

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	CHMP summary of positive opinion for Duavive

Name of medicine	Lynparza
INN	olaparib
Marketing-authorisation applicant	AstraZeneca AB
Therapeutic indication	Treatment of ovarian cancer
More information	CHMP summary of positive opinion for Lynparza
	Press release: Lynparza recommended for approval in ovarian cancer

Name of medicine	Rixubis
INN	nonacog gamma
Marketing-authorisation applicant	Baxter Innovations GmbH
Therapeutic indication	Treatment and prophylaxis of bleeding in patients with haemophilia B
More information	CHMP summary of positive opinion for Rixubis

Name of medicine	Scenesse
INN	afamelanotide
Marketing-authorisation applicant	Clinuvel (UK) Limited
Therapeutic indication	Treatment of phototoxicity
More information	CHMP summary of positive 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
INN	duloxetine
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	CHMP summary of positive opinion for Duloxetine Lilly

Name of medicine	Paliperidone Janssen
INN	paliperidone
Marketing-authorisation applicant	Janssen-Cilag International NV
Therapeutic indication	Treatment of schizophrenia
More information	CHMP summary of positive opinion for Paliperidone Janssen

Positive recommendation on extension of therapeutic indication

Name of medicine	Xtandi
INN	enzalutamide
Marketing-authorisation holder	Astellas Pharma Europe B.V.
More information	CHMP post-authorisation summary of positive opinion for Xtandi

Public-health recommendations

Name of medicine	Iclusig
INN	ponatinib
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
More information	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
INN	felodipine
Marketing-authorisation holder	Astra Zeneca group of companies and associated companies
More information	Questions and answers on Plendil and associated names