Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Biogen Gets Data Protection in EU | Contract Pharma

What are you searching for?

Sign in
Trials & Filings

Biogen Gets Data Protection in EU

MS drug gets NAS designtation

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has determined that dimethyl fumarate in Biogen Idec‘s MS treatment Tecfidera (dimethyl fumarate) qualifies as a new active substance (NAS). This designation will provide 10 years of regulatory exclusivity for Tecfidera in the EU.

The NAS determination follows a positive opinion by the CHMP in March 2013 recommending marketing authorization in the EU for Tecfidera as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). The CHMP’s determination will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the EU.

Tecfidera is approved in the U.S., but was delayed in Europe because of data issues. Dimethyl fumarate, the API in Tecfidera, is used in Fumaderm, a psoriasis drug marketed by Biogen Idec. The MS treatment uses a different formulation of that generic API, and the issue of data protection was seen as a deal-breaker for Tecfidera reaching the EU market.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics