Tecfidera wins “new active substance” designation in Europe

November 22,2013 | By Márcio Barra

I have to add Aubagio to this image

Biogen Idec’s multiple sclerosis drug Tecfidera (dymethil Fumarate ) won today designation as a “new active substance” in Europe by the European Medicines Agency, giving it added protection against generic copies and paving the way its approval in European soil.

The designation, issued by the Committee for Medicinal Products for Human Use and posted today on the EMA’s website, gives an additional 10 years of patent protection for Tecfidera, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) posted this decision on its website today, updating a previous opinion.

The drug, cleared in the U.S. and recommended for approval in Europe in March, is the leading oral Multiple Sclerosis treatment in the U.S., being the most-prescribed pill for relapsing-remitting Multiple Sclerosis , easily beating its oral competition – Sanofi’s Aubagio (teriflunomide) and Novartis’ Gilenya (fingolimod )- reaching 13% of market share its own compared with their combined 12.3%. Tecfidera’s success owes much to its safety profile in comparison to the competiton. Aubagio carries the risk of liver injury, birth defects and comes along with a boxed warning, and Gilenya, although first to market, has been held back by heart safety concerns. Tecfidera only causes a decrease in a person’s white blood cell count, alongside nausea, vomiting, and diarrhea, which tended to get better over time without stopping the drug. The drug also has a price of $54,900 per patient per year, cheaper than Gilenya ($60,000 per patient per year), but more expensive than Aubagio ($48,000 per year).

Bloomberg reports that Tecfidera is expected to be approved by the European Comission by January, with sales starting in the first quarter of 2014.

This drug acts primarily by activating the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) transcriptional pathway, which helps protect nerve cells from damage and inflammation, thus easing multiple sclerosis symptoms like muscle weakness and difficulty with coordination and balance.



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