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

News 19/12/2014

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 medicineHoloclar
Common name(ex-vivo) autologous corneal epithelial cells including stem cells
Marketing-authorisation applicantChiesi Farmaceutici S.p.A.
Therapeutic indicationTreatment of limbal stem cell deficiency
More information

PDF iconSummary of opinion for Holoclar

Press release: First stem-cell therapy recommended for approval in EU

Name of medicineMysimba
International non-proprietary name (INN)naltrexone / bupropion
Marketing-authorisation applicantOrexigen Therapeutics Ireland Limited
Therapeutic indicationManagement of obesity
More information

PDF iconSummary of opinion for Mysimba

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

Name of medicineQuinsair
INNlevofloxacin
Marketing-authorisation applicantAptalis Pharma SAS
Therapeutic indicationTreatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis
More information PDF iconSummary of opinion for Quinsair

Name of medicineXadago
INNsafinamide
Marketing-authorisation applicantZambon SpA
Therapeutic indicationTreatment of Parkinson's disease
More information PDF iconSummary of opinion for Xadago

Name of medicineXydalba
INNdalbavancin
Marketing-authorisation applicantDurata Therapeutics International B.V.
Therapeutic indicationTreatment of skin and skin structure infections
More information PDF iconSummary of opinion for Xydalba

Positive recommendation on new informed-consent application

Name of medicineTasermity
INNsevelamer hydrochloride
Marketing-authorisation applicantGenzyme Europe BV
Therapeutic indicationControl of hyperphosphataemia
More information PDF iconSummary of opinion for Tasermity

Positive recommendation on new generic medicine

Name of medicineClopidogrel ratiopharm
INNclopidogrel
Marketing-authorisation applicantTeva 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 PDF iconSummary of opinion for Clopidogrel ratiopharm

Positive recommendations on extensions of therapeutic indications

Name of medicineRevlimid
INNlenalidomide
Marketing-authorisation holderCelgene Europe Limited
More information PDF iconSummary of opinion for Revlimid

Name of medicineTresiba
INNinsulin degludec
Marketing-authorisation holderNovo Nordisk A/S
More information PDF iconSummary of opinion for Tresiba

Name of medicineVelcade
INNbortezomib
Marketing-authorisation holderJanssen-Cilag International N.V.
More information PDF iconSummary of opinion for Velcade

Name of medicineXiapex
INNcollagenase clostridium histolyticum
Marketing-authorisation holderSwedish Orphan Biovitrum AB
More information PDF iconSummary of opinion for Xiapex

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
Start of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in November 2014 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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