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

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23/01/2015

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.

 

CHMP January 2015

 

Positive recommendations on new medicines

Name of medicineDutrebis
International non-proprietary name (INN)lamivudine / raltegravir
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationTreatment of human immunodeficiency virus (HIV-1)
More informationSummary of opinion for Dutrebis

 

Name of medicineIkervis
INNciclosporin
Marketing-authorisation applicantSanten SAS
Therapeutic indicationTreatment of severe keratitis
More informationSummary of opinion for Ikervis

 

Name of medicineKengrexal
INNcangrelor
Marketing-authorisation applicantThe Medicines Company UK Ltd
Therapeutic indicationReduction of thrombotic cardiovascular events
More informationSummary of opinion for Kengrexal

 

Name of medicineOrbactiv
INNoritavancin
Marketing-authorisation applicantThe Medicines Company UK Ltd
Therapeutic indicationTreatment of acute bacterial skin and skin structure infections
More informationSummary of opinion for Orbactiv

 

Name of medicineRaplixa
INNhuman fibrinogen / human thrombin
Marketing-authorisation applicantProFibrix BV
Therapeutic indicationSupportive treatment where standard surgical techniques are insufficient for improvement of haemostasis
More informationSummary of opinion for Raplixa

 

Name of medicineSaxenda
INNliraglutide
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of obesity
More information

Summary of opinion for Saxenda

 

Press release: Saxenda recommended for approval in weight management in adults

 

Name of medicineSivextro
INNtedizolid phosphate
Marketing-authorisation applicantCubist
Therapeutic indicationTreatment of acute bacterial skin and skin structure infections
More informationSummary of opinion for Sivextro

  

Positive recommendations on new therapeutic indications

Name of medicineAbraxane
INNpaclitaxel
Marketing-authorisation holderCelgene Europe Limited
More informationSummary of opinion for Abraxane

 

Name of medicineAloxi
INNpalonosetron
Marketing-authorisation holderHelsinn Birex Pharmaceuticals Ltd
More informationSummary of opinion for Aloxi

 

Name of medicineEylea
INNaflibercept
Marketing-authorisation holderBayer Pharma AG
More informationSummary of opinion for Eylea

 

Name of medicineJakavi
INNruxolitinib
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Jakavi

 

Name of medicinePrevenar 13
INNpneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Marketing-authorisation holderPfizer Limited
More informationSummary of opinion for Prevenar 13

 

Public-health recommendation

Name of referralGVK Biosciences
More informationGVK Biosciences

 

Withdrawal of application

Name of medicineTeysuno
More informationQuestions and answers on Teysuno

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu