Meeting highlights from the Committee for Medicinal Products for Human Use

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 on the website 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 on the website 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 on the website 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 in the link below.

For an overview of all information available on the meeting of the CHMP, please click here.