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

News 27/02/2015

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 medicineJinarc
International non-proprietary name (INN)tolvaptan
Marketing-authorisation applicantOtsuka Pharmaceutical Europe Ltd
Therapeutic indicationTreatment of kidney disease
More information PDF icon Summary of opinion for Jinarc
 Press release: Jinarc recommended for approval in rare kidney disease


Name of medicineZykadia
International non-proprietary name (INN)ceritinib
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of anaplastic lymphomakinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)
More information PDF icon Summary of 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 medicineRistempa
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of neutropenia
More information PDF icon Summary of opinion for Ristempa


Positive recommendations on new therapeutic indications

Name of medicineAdenuric
Marketing-authorisation holderMenarini International Operations Luxembourg S.A.
More information PDF icon Summary of opinion for Adenuric


Name of medicineAvastin
Marketing-authorisation holderRoche Registration Ltd
More information PDF icon Summary of opinion for Avastin


Name of medicineHumira
Marketing-authorisation holderAbbVie Ltd.
More information PDF icon Summary of opinion for Humira


Name of medicineSoliris
Marketing-authorisation holderAlexion Europe SAS
More information PDF icon Summary of opinion for Soliris


Name of medicineSustiva
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF icon Summary of opinion for Sustiva


Name of medicineVectibix
Marketing-authorisation holderAmgen Europe B.V.
More information PDF icon Summary of opinion for Vectibix


Withdrawal of application

Name of medicineRienso
More information PDF icon Questions and answers on Rienso


Other opinions

Name of medicineToujeo
INNinsulin glargine
Marketing-authorisation holderSanofi-Aventis Deutschland GmbH
More information PDF icon Summary of opinion for Toujeo


Other updates

PDF icon Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF icon Opinions on safety variations
Start of Community reviews
PDF icon Scientific advice and protocol assistance
Guidelines and concept papers adopted
PDF icon Overview of invented names reviewed in January 2015 by the Name Review Group (NRG)
PDF icon Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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