Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 2016

News 29/01/2016

Six medicines, of which two have been fast-tracked, receive positive opinions from the Committee

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorisation at its January 2016 meeting.

The CHMP recommended granting a marketing authorisation, under accelerated assessment, for Empliciti (elotuzumab) for the treatment of multiple myeloma. Empliciti is to be used in combination with lenalidomide and dexamethasone for the treatment of patients who have received at least one prior therapy. Empliciti has an orphan designation. For more details, please refer to the press release in the grid below.

The Committee recommended granting a marketing authorisation for Coagadex (factor X), for the treatment of factor X deficiency, a rare inherited bleeding disorder. Coagadex has an orphan designation and was reviewed under accelerated assessment. For more details, please refer to the press release in the grid below.

Uptravi (selexipag) was recommended by the Committee for the treatment of pulmonary arterial hypertension. Uptravi has an orphan designation.

Three generic medicines received a positive opinion from the Committee: Amlodipine-Valsartan Mylan (amlodipine/valsartan) for the treatment of essential hypertension, Rasagiline Mylan (rasagiline) for the treatment of idiopathic Parkinson's disease and Zonisamide Mylan (zonisamide) for the treatment of partial seizures, with or without secondary generalisation.

Two recommendations on extensions of therapeutic indications

The Committee recommended extensions of indication for Revlimid and Revolade.

Request for re-examination of CHMP recommendation

The applicant for Dropcys (mercaptamine hydrochloride) has requested a re-examination of the CHMP's negative opinion for this medicine adopted at the December 2015 meeting. Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine this opinion and issue a final opinion.

Review of metformin-containing medicines started

The CHMP has started a review of all metformin-containing medicines. Metformin, alone or in combination with other medicines, is widely used for treating type 2 diabetes. This review was requested by the Dutch medicines agency (the Medicines Evaluation Board, MEB) following a routine evaluation which showed that the prescribing information of these medicines varies in its advice on how the medicine should be used in patients with reduced kidney function. For more information, please see the start of referral document in the grid below.

Update on Ebola

The CHMP has adopted a final scientific opinion following its review of experimental Ebola treatments. The final report includes information on nine experimental medicines intended for the treatment of people infected with the Ebola virus: BCX4430, Brincidofovir, Favipiravir, TKM-Ebola, AVI-7537, ZMapp, Anti-Ebola F(ab')2, GS-5734 and Ebotab. The assessment report for this review will be published shortly.

Withdrawal of application

An application for marketing authorisation for Aripiprazole Mylan (aripiprazole) has been withdrawn. A question-and-answer document on this withdrawal is available below.

Agenda and minutes

The agenda of the January 2016 meeting is published on EMA's website. Minutes of the December 2015 CHMP meeting will be published next week.

CHMP statistics

Key figures from the January 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP's January 2016 meeting, is available in the grid below.

Download image in PDF format

Positive recommendations on new medicines

Name of medicineCoagadex
International non-proprietary name (INN)factor X
Marketing-authorisation applicantBio Products Laboratory
Therapeutic indicationTreatment of factor X deficiency
More information

PDF iconSummary of opinion for Coagadex

Press release: First specific replacement therapy to treat rare bleeding disorder

Name of medicineEmpliciti
INNelotuzumab
Marketing-authorisation applicantBristol-Myers Squibb
Therapeutic indicationTreatment of multiple myeloma
More information

PDF iconSummary of opinion for Empliciti

Press release: EMA fast-tracks treatment of multiple myeloma for approval in EU

Name of medicineUptravi
INNselexipag
Marketing-authorisation applicantActelion Registration Ltd
Therapeutic indicationTreatment of pulmonary arterial hypertension
More information PDF iconSummary of opinion for Uptravi

Positive recommendations on new generic medicines

Name of medicineAmlodipine-Valsartan Mylan
INNamlodipine / valsartan
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationTreatment of essential hypertension
More information PDF iconSummary of opinion for Amlodipine-Valsartan Mylan

Name of medicineRasagiline Mylan
INNrasagiline
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationTreatment of idiopathic Parkinson's disease
More information PDF iconSummary of opinion for Rasagiline Mylan

Name of medicineZonisamide Mylan
INNzonisamide
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationTreatment of partial seizures, with or without secondary generalisation
More information PDF iconSummary of opinion for Zonisamide Mylan

Positive recommendations on extensions of therapeutic indications

Name of medicineRevlimid
INNlenalidomide
Marketing-authorisation holderCelgene Europe Limited
More informationSummary of opinion on Revlimid

Name of medicineRevolade
INNeltrombopag / eltrombopag olamine
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion on Revolade

Start of referral

Name of medicineMetformin and metformin containing fixed-dose combinations
INNmetformin
More informationStart of Article-31 referral

Outcome of arbitration procedure

Name of medicineTobramycin VVB and associated names
INNtobramycin
Marketing-authorisation holderUAB VVB
More informationQuestions and answers on Tobramycin VVB and associated names

Withdrawal of application

Name of medicineAripiprazole Mylan
INNaripiprazole
More information PDF iconQuestions and answers on Aripiprazole Mylan

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
Guidelines and concept papers adopted
PDF iconOrganisational matters

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