Please login to the form below

Not currently logged in
Email:
Password:

EU approval for Gilenya

Novartis' oral multiple sclerosis drug Gilenya has been approved as the first treatment of its kind for use in the European Union

Novartis' oral multiple sclerosis (MS) drug Gilenya (fingolimod) has been approved as the first treatment of its kind for use in the European Union (EU).

The drug is approved for use in patients with highly active relapsing-remitting multiple sclerosis (RRMS) who have already undergone treatment with beta interferon, or have a rapidly evolving severe form of the condition.

The announcement follows the US Food and Drug Administration's (FDA) decision to approve Gilenya for use in the US after trials showed it reduced the frequency of relapse and reduced the risk of disease progression.

It has also been approved in other regions including Switzerland and Australia.

The EU approval was preceded by a positive opinion of Gilenya from the Committee for Medicinal Products for Human Use (CHMP), an expert committee of the European Medicines Agency (EMA).

Gilenya has fared better than other oral MS treatments, including Merck Serono's cladribine. Despite being approved in Russia under the trade name Movectro, it was recently denied US approval and was given a negative opinion by CHMP.

21st March 2011

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Onyx Health Ltd

Onyx Health is a healthcare communications and PR agency based in the North East of England, but with a national...

Latest intelligence

Patient-centricity in improving patient recruitment advertising
This blog looks into the importance of concepts and patient centricity in patient recruitment....
AI and life sciences
AI: the smart money is on the smart thinking
Looking at the three key areas where AI is being applied: drug discovery, clinical decision-making and clinical trials...
Virtual Engagement At Porterhouse: Reflections on the past few months
A look at how the pitfalls of virtual engagement can be avoided and the key advantages of virtual client and KOL engagement strategies in a now predominantly digital world....

Infographics