Ten new medicines, two orphans, recommended for approval

Ten new medicines have been recommended for approval at the November 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended granting a marketing authorisation for Cerdelga (eliglustat), an orphan medicine for the treatment of Gaucher disease type 1. For more information please see the press release in the grid below.

The Committee also gave positive opinions for Exviera (dasabuvir) and Viekirax (ombitasvir + paritaprevir + ritonavir) for the treatment of chronic hepatitis C. Both products were reviewed under accelerated assessment and belong to a new generation of antiviral products for chronic hepatitis C infection that have high cure rates and have recently reshaped the treatment landscape for the disease. For more information please see the press release in the grid below.

The orphan medicine Ofev (nintedanib) received a positive opinion for the treatment of idiopathic pulmonary fibrosis.

Cosentyx (secukinumab) and Otezla (apremilast) were recommended by the CHMP as new treatment options for psoriasis.

Senshio (ospemifene) received a positive opinion for the treatment of vulvar and vaginal atrophy and Zontivity (vorapaxar) was recommended for the reduction of atherothrombotic events.

The CHMP also granted positive opinions for two new informed consent applications: Sevelamer carbonate Zentiva (sevelamer) for the control of hyperphosphataemia in adults receiving haemodialysis or peritoneal dialysis and Rasagiline ratiopharm (rasagiline) for the treatment of Parkinson’s disease. An informed consent application is based on data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Two recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Inductos and Travatan.

Change to non-prescription status

The CHMP recommended a change in classification status from prescription to non-prescription for the emergency contraceptive ellaOne (ulipristal acetate). For more information, please see the press release in the grid below.

Outcome of safety review

The CHMP concluded its review of Corlentor/Procoralan (ivabradine) and made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine for angina. Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.

Update on Tecfidera

The CHMP discussed a fatal case of progressive multifocal leukoencephalopathy (PML) which was reported in a patient treated with Tecfidera (dimethyl fumarate), a medicine used for relapsing-remitting multiple sclerosis. This is the first case of PML, a rare viral brain infection with symptoms that can be similar to those of a multiple sclerosis attack, to be reported in association with Tecfidera. The fatal case of PML occurred after long-term treatment with the medicine in a patient experiencing severe long-term lymphopenia, a known possible side effect of Tecfidera.

The CHMP recommended that a letter is sent to healthcare professionals to alert them to the potential risk of PML and to allow them to inform their patients.

Withdrawals of applications

The application for a marketing authorisation for Egranli has been withdrawn. For more information, please see the question-and-answer document in the grid below.

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

More information on other outcomes of the November 2014 CHMP meeting, is available in the grid below.

Agenda and minutes

The agenda of the November 2014 meeting is published on the EMA website. The minutes of the October meeting will be published during the week following the November CHMP meeting.


Posted on the EMA website on 21 November 2014