Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 February 2015

Three new medicines, including one orphan, recommended for approval

Three new medicines have been recommended for approval at the February 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

The Committee has recommended granting a marketing authorisation for Jinarc (tolvaptan) for the treatment of patients with autosomal dominant polycystic kidney disease (ADPKD). Jinarc has an orphan designation. For more information please see the press release in the grid below.

The CHMP has recommended granting a conditional marketing authorisation for Zykadia (ceritinib) for the treatment of adult patients with a type of lung cancer called anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), when the disease is advanced and has already been treated with crizotinib. A conditional marketing authorisation is granted for a medicine that meets unmet medical needs of patients and is in the interest of public health, before all of the formal studies on its efficacy and safety have been completed. It is one of the mechanisms available to the European Medicines Agency (EMA) to facilitate market access for medicines that fulfill unmet medical needs. For more information on Zykadia, please see the press release in the grid below.

The CHMP also granted a positive opinion for the informed consent application Ristempa (pegfilgrastim), for the treatment of neutropenia. In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Adenuric, Avastin, Humira, Soliris, Sustiva and Vectibix.

Recommendation on a new formulation for a medicine to treat diabetes

The CHMP recommended the addition of a new formulation to the marketing authorisation of Optisulin (insulin glargine) and a change of its invented name to Toujeo. The new formulation of Toujeo is a higher-strength insulin (300 units/ml). Insulin glargine was first authorised in the European Union as a 100 units/ml formulation as Lantus and Optisulin in June 2000.

Update on GVK Biosciences review

Following the CHMP's January 2015 recommendation to suspend marketing authorisations of a number of medicines for which authorisations were primarily based on clinical studies conducted at GVK Biosciences, some marketing authorisation holders have requested a re-examination. Once the grounds for re-examination are received by EMA from these marketing authorisation holders (the deadline is 30 March 2015), the CHMP will start a re-examination. The re-examination will conclude within 60 days.

Withdrawal of application

An application for an extension of therapeutic indication for Rienso has been withdrawn. A question-and-answer document on this withdrawal is available below.

Agenda and minutes

The agenda of the February 2015 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the March CHMP meeting.

CHMP statistics

Key figures from the February 2015 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP February 2015 meeting, is available in the grid below.

Positive recommendation on new medicine

Name of medicine	Jinarc
International non-proprietary name (INN)	tolvaptan
Marketing-authorisation applicant	Otsuka Pharmaceutical Europe Ltd
Therapeutic indication	Treatment of kidney disease
More information	CHMP summary of positive opinion for Jinarc
	Press release: Jinarc recommended for approval in rare kidney disease

Name of medicine	Zykadia
International non-proprietary name (INN)	ceritinib
Marketing-authorisation applicant	Novartis Europharm Ltd
Therapeutic indication	Treatment of anaplastic lymphomakinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
More information	CHMP summary of positive opinion for Zykadia
	Press release: Zykadia recommended for approval in advanced non small cell lung cancer

Positive recommendation on new informed-consent application

Name of medicine	Ristempa
INN	pegfilgrastim
Marketing-authorisation applicant	Amgen Europe B.V.
Therapeutic indication	Treatment of neutropenia
More information	CHMP summary of positive opinion for Ristempa

Positive recommendations on new therapeutic indications

Name of medicine	Adenuric
INN	febuxostat
Marketing-authorisation holder	Menarini International Operations Luxembourg S.A.
More information	CHMP post-authorisation summary of positive opinion for Adenuric

Name of medicine	Avastin
INN	bevacizumab
Marketing-authorisation holder	Roche Registration Ltd
More information	CHMP post-authorisation summary of positive opinion for Avastin

Name of medicine	Humira
INN	adalimumab
Marketing-authorisation holder	AbbVie Ltd.
More information	CHMP post-authorisation summary of positive opinion for Humira

Name of medicine	Soliris
INN	eculizumab
Marketing-authorisation holder	Alexion Europe SAS
More information	CHMP post-authorisation summary of positive opinion for Soliris

Name of medicine	Sustiva
INN	efavirenz
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	CHMP post-authorisation summary of positive opinion for Sustiva

Name of medicine	Vectibix
INN	panitumumab
Marketing-authorisation holder	Amgen Europe B.V.
More information	CHMP post-authorisation summary of positive opinion for Vectibix

Withdrawal of application

Name of medicine	Rienso
More information	Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Rienso (ferumoxytol)

Other opinions

Name of medicine	Toujeo
INN	insulin glargine
Marketing-authorisation holder	Sanofi-Aventis Deutschland GmbH
More information	CHMP post-authorisation summary of positive opinion for Toujeo