CHMP News – January 2016


Six medicines receive positive opinions from CHMP

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 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.

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.

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.

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 here.

More information on the CHMP's January 2016 meeting can be found here.