Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 January 2015

Seven new medicines recommended for approval

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

The Committee has recommended granting a marketing authorisation for Saxenda (liraglutide) 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.

The CHMP also gave positive opinions for Orbactiv (oritavancin) and Sivextro (tedizolid phosphate), two antibiotics for the treatment of acute bacterial skin and skin structure infections.

Dutrebis (lamivudine / raltegravir) was recommended by the Committee as a new treatment option for human immunodeficiency virus (HIV-1).

Ikervis (ciclosporin) was recommended for the treatment of severe keratitis, an eye condition in which the cornea becomes inflamed.

Kengrexal (cangrelor) received a positive opinion from the Committee for the reduction of thrombotic cardiovascular events and Raplixa (human fibrinogen / human thrombin) received a positive opinion as a supportive treatment where standard surgical techniques are insufficient for the improvement of haemostasis.

Five recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for Abraxane, Aloxi, Eylea, Jakavi and Prevenar 13.

Outcome of GVK Biosciences review

The CHMP concluded that a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, unless they are of critical importance for patients because alternatives will not be able to meet patients' needs. The CHMP's recommendation is based on findings from an inspection that raised concerns over how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders.

For more information on the review, and for the list of affected medicines, please see the public health communication in the grid below.

Withdrawal of application

An application for extension of therapeutic indication for Teysuno has been withdrawn.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

Agenda and minutes

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

CHMP statistics

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

Positive recommendations on new medicines

Name of medicine	Dutrebis
International non-proprietary name (INN)	lamivudine / raltegravir
Marketing-authorisation applicant	Merck Sharp & Dohme Limited
Therapeutic indication	Treatment of human immunodeficiency virus (HIV-1)
More information	CHMP summary of positive opinion for Dutrebis

Name of medicine	Ikervis
INN	ciclosporin
Marketing-authorisation applicant	Santen SAS
Therapeutic indication	Treatment of severe keratitis
More information	CHMP summary of positive opinion for Ikervis

Name of medicine	Kengrexal
INN	cangrelor
Marketing-authorisation applicant	The Medicines Company UK Ltd
Therapeutic indication	Reduction of thrombotic cardiovascular events
More information	CHMP summary of positive opinion for Kengrexal

Name of medicine	Orbactiv
INN	oritavancin
Marketing-authorisation applicant	The Medicines Company UK Ltd
Therapeutic indication	Treatment of acute bacterial skin and skin structure infections
More information	CHMP summary of positive opinion for Orbactiv

Name of medicine	Raplixa
INN	human fibrinogen / human thrombin
Marketing-authorisation applicant	ProFibrix BV
Therapeutic indication	Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis
More information

Name of medicine	Saxenda
INN	liraglutide
Marketing-authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Treatment of obesity
More information	CHMP summary of positive opinion for Saxenda Press release: Saxenda recommended for approval in weight management in adults

Name of medicine	Sivextro
INN	tedizolid phosphate
Marketing-authorisation applicant	Cubist
Therapeutic indication	Treatment of acute bacterial skin and skin structure infections
More information	CHMP summary of positive opinion for Sivextro

Positive recommendations on new therapeutic indications

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

Name of medicine	Aloxi
INN	palonosetron
Marketing-authorisation holder	Helsinn Birex Pharmaceuticals Ltd
More information	CHMP post-authorisation summary of positive opinion for Aloxi

Name of medicine	Eylea
INN	aflibercept
Marketing-authorisation holder	Bayer Pharma AG
More information	CHMP post-authorisation summary of positive opinion for Eylea

Name of medicine	Jakavi
INN	ruxolitinib
Marketing-authorisation holder	Novartis Europharm Ltd
More information	CHMP post-authorisation summary of positive opinion for Jakavi

Name of medicine	Prevenar 13
INN	pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Marketing-authorisation holder	Pfizer Limited
More information	CHMP post-authorisation summary of positive opinion for Prevenar 13

Public-health recommendation

Name of referral	GVK Biosciences
More information	GVK Biosciences

Withdrawal of application

Name of medicine	Teysuno
More information	Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Teysuno (tegafur/gimeracil/oteracil)