Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014

News 21/03/2014

This page provides an overview of the opinions adopted at the March 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Nine new medicines recommended for approval

The CHMP has recommended granting a marketing authorisation for Vynfinit (vintafolide) for the treatment of women with a sub-type of platinum-resistant ovarian cancer for which there are limited approved treatment options. The CHMP has recommended approval for Vynfinit together with the approval of two companion diagnostic medicines, Folcepri (etarfolatide) and Neocepri (folic acid) that will help identify patients who may benefit from treatment with Vynfinit. All three of these medicines have an orphan designation and were recommended for conditional marketing authorisations. Please see the press release in the grid below for more details.

The CHMP has recommended the granting of a marketing authorisation for Sylvant (siltuximab), a medicine for the treatment of adult patients with multicentric Castleman's disease. Sylvant has an orphan designation and was evaluated by accelerated assessment. Please see the press release in the grid below for more information.

The CHMP also gave a positive recommendation for Entyvio (vedolizumab) for the treatment of ulcerative colitis and Crohn's disease. Please see the press release in the grid below for more details.

The Committee also recommended the granting of a marketing authorisation for Jardiance (empagliflozin) for the treatment of type 2 diabetes.

Olysio (simeprevir) was recommended for marketing authorisation for the treatment of chronic hepatitis C in adult patients in combination with other medicinal products.

Revinty Ellipta (fluticasone furoate /vilanterol trifenatate) for the treatment of asthma and chronic obstructive pulmonary disease (COPD) was also recommended for approval by the Committee. This product was submitted as an informed consent application.

The generic medicine Ebilfumin (oseltamivir) also received a positive opinion from the CHMP for the prevention and treatment of influenza. Ebilfumin is a generic of Tamiflu.

Three recommendations on extensions of therapeutic indications

The CHMP recommended extensions of indications for Pegasys, Tresiba and Victoza.

Outcome of safety review

The CHMP concluded its review of the safety of propylene glycol in intravenous formulations for short-term use in children. The assessment report for this review will be published next week.

Recommendation on seasonal influenza vaccine for 2014-1015

The CHMP adopted EU-wide recommendations for the influenza virus strains that should be included in vaccines for the prevention of seasonal influenza next winter. For more information, please click here.

Agenda and minutes

The agenda of the March 2014 meeting is published on the EMA website. The minutes of the meeting will be published during the week following the April CHMP meeting. Minutes of the February 2014 CHMP meeting will be published next week.

CHMP statistics

Key figures from the March 2014 CHMP meeting are represented in the graphic below.




Positive recommendations on new medicines

Name of medicineEntyvio
International non-proprietary name (INN)vedolizumab
Marketing-authorisation applicantTakeda Pharma A/S
Therapeutic indicationTreatment of ulcerative colitis and Crohn's disease
More information PDF iconSummary of opinion for Entyvio

Press release: European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease

Name of medicineFolcepri
INNetarfolatide
Marketing-authorisation applicantEndocyte Europe, B.V
Therapeutic indicationIndicated for single photon emission computed tomography (SPECT) imaging
More information PDF iconSummary of opinion for Folcepri

Press release: European Medicines Agency recommends approval of new treatment for platinum-resistant ovarian cancer together with companion diagnostic

Name of medicineJardiance
INNempagliflozin
Marketing-authorisation applicantBoehringer Ingelheim International GmbH
Therapeutic indicationTreatment of type II diabetes mellitus
More information PDF iconSummary of opinion for Jardiance

Name of medicineNeocepri
INNfolic acid
Marketing-authorisation applicantEndocyte Europe, B.V.
Therapeutic indicationIndicated for the enhancement of 99mTc-etarfolatide single photon emission computed tomography (SPECT) image quality
More information PDF iconSummary of opinion for Neocepri

Press release: European Medicines Agency recommends approval of new treatment for platinum-resistant ovarian cancer together with companion diagnostic

Name of medicineOlysio
INNsimeprevir
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationIndicated in combination with other medicinal products for the treatment of chronic hepatitis C in adult patients
More information PDF iconSummary of opinion for Olysio

Name of medicineVynfinit
INNvintafolide
Marketing-authorisation applicantEndocyte Europe, B.V.
Therapeutic indicationTreatment of platinum resistant ovarian cancer
More information PDF iconSummary of opinion for Vynfinit

Press release: European Medicines Agency recommends approval of new treatment for platinum-resistant ovarian cancer together with companion diagnostic

Name of medicineSylvant
INNsiltuximab
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of multicentric Castleman's disease
More information PDF iconSummary of opinion for Sylvant

Press release: European medicines Agency recommends authorisation of first medicine for Castleman's disease

Positive recommendation on new informed-consent application

Name of medicineRevinty Ellipta
INNfluticasone furoate / vilanterol trifenatate
Marketing-authorisation applicantGlaxo Group Ltd
Therapeutic indicationTreatment of asthma and chronic obstructive pulmonary disease
More information PDF iconSummary of opinion for Revinty Ellipta

Positive recommendation on new generic medicine

Name of medicineEbilfumin
INNoseltamivir
Marketing-authorisation applicantActavis Group PTC ehf
Therapeutic indicationTreatment and prevention of influenza
More information PDF iconSummary of opinion for Ebilfumin

Positive recommendations on extensions of therapeutic indications

Name of medicinePegasys
INNpeginterferon alfa-2a
Marketing-authorisation holderRoche Registration Limited
More information PDF iconSummary of opinion for Pegasys

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

Name of medicineVictoza
INNliraglutide
Marketing-authorisation holderNovo Nordisk A/S
More information PDF iconSummary of opinion for Victoza

Re-examination of initial recommendation for marketing authorisation

Name of medicineMasican
INNmasitinib
Marketing-authorisation holderAB Science
More information PDF iconQuestions and answers on refusal of the marketing authorisation for Masican

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOrganisational matters

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