Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 2014

Seven new medicines recommended for approval in December 2014, 82 overall in 2014

Seven new medicines have been recommended for marketing authorisation at the December 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP). This brings the total number of medicines recommended for approval by the CHMP in 2014 to 82.

The CHMP has recommended granting a conditional marketing authorisation for the orphan medicine Holoclar for the treatment of moderate to severe limbal stem cell deficiency due to physical or chemical burns to the eyes in adults. Holoclar is the first advanced therapy medicine containing stem cells to be recommended for approval in the European Union. For more information please see the press release in the grid below.

The Committee also gave a positive opinion for Mysimba (naltrexone / bupropion) for weight management in adults who are obese, or those who are overweight and have one or more complications related to their weight. The medicine is recommended for use in addition to a reduced-calorie diet and physical activity. For more information please see the press release in the grid below.

Xadago (safinamide) received a positive opinion for the treatment of Parkinson's disease.

Xydalba (dalbavancin) received a positive opinion for the treatment of skin and skin structure infections. The orphan medicine Quinsair (levofloxacin) has been recommended for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.

The CHMP granted a positive opinion for the informed consent application Tasermity (sevelamer hydrochloride) for the control of hyperphosphataemia in adults receiving dialysis. 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.

The generic medicine Clopidogrel ratiopharm (clopidogrel) received a positive opinion for the prevention of myocardial infarction, ischaemic stroke, peripheral arterial disease and acute coronary syndrome, as well as the prevention of atherothrombotic and thromboembolic events in atrial fibrillation.

Four recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for four medicines: Revlimid, Tresiba, Velcade and Xiapex.

Update on GVK Biosciences review

The review procedure for GVK Biosciences is ongoing. In line with the published timetable, the CHMP is expected to give a recommendation on this issue following its January 2015 meeting.

Agenda and minutes

The agenda of the December 2014 meeting is published on the EMA website. The minutes of the December meeting will be published during the week following the January 2015 CHMP meeting.

CHMP statistics

Key figures from the December 2014 CHMP meeting and overall figures for 2014 are represented in the graphic below.

Positive recommendations on new medicines

Name of medicine	Holoclar
Common name	(ex-vivo) autologous corneal epithelial cells including stem cells
Marketing-authorisation applicant	Chiesi Farmaceutici S.p.A.
Therapeutic indication	Treatment of limbal stem cell deficiency
More information	CHMP summary of positive opinion for Holoclar Press release: First stem-cell therapy recommended for approval in EU

Name of medicine	Mysimba
International non-proprietary name (INN)	naltrexone / bupropion
Marketing-authorisation applicant	Orexigen Therapeutics Ireland Limited
Therapeutic indication	Management of obesity
More information	CHMP summary of positive opinion for Mysimba Press release: Mysimba recommended for approval in weight management in adults

Name of medicine	Quinsair
INN	levofloxacin
Marketing-authorisation applicant	Aptalis Pharma SAS
Therapeutic indication	Treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis
More information	CHMP summary of positive opinion for Quinsair

Name of medicine	Xadago
INN	safinamide
Marketing-authorisation applicant	Zambon SpA
Therapeutic indication	Treatment of Parkinson's disease
More information	CHMP summary of positive opinion for Xadago

Name of medicine	Xydalba
INN	dalbavancin
Marketing-authorisation applicant	Durata Therapeutics International B.V.
Therapeutic indication	Treatment of skin and skin structure infections
More information	CHMP summary of positive opinion for Xydalba

Positive recommendation on new informed-consent application

Name of medicine	Tasermity
INN	sevelamer hydrochloride
Marketing-authorisation applicant	Genzyme Europe BV
Therapeutic indication	Control of hyperphosphataemia
More information	CHMP summary of positive opinion for Tasermity

Positive recommendation on new generic medicine

Name of medicine	Clopidogrel ratiopharm
INN	clopidogrel
Marketing-authorisation applicant	Teva Pharma B.V.
Therapeutic indication	Prevention of myocardial infarction, ischaemic stroke, peripheral arterial disease, acute coronary syndrome; Prevention of atherothrombotic and thromboembolic events in atrial fibrillation
More information	CHMP summary of positive opinion for Clopidogrel ratiopharm

Positive recommendations on extensions of therapeutic indications

Name of medicine	Revlimid
INN	lenalidomide
Marketing-authorisation holder	Celgene Europe Limited
More information	CHMP post-authorisation summary of positive opinion for Revlimid

Name of medicine	Tresiba
INN	insulin degludec
Marketing-authorisation holder	Novo Nordisk A/S
More information	CHMP post-authorisation summary of positive opinion for Tresiba

Name of medicine	Velcade
INN	bortezomib
Marketing-authorisation holder	Janssen-Cilag International N.V.
More information	CHMP post-authorisation summary of positive opinion for Velcade

Name of medicine	Xiapex
INN	collagenase clostridium histolyticum
Marketing-authorisation holder	Swedish Orphan Biovitrum AB
More information	CHMP post-authorisation summary of positive opinion for Xiapex