Tecfidera, from Biogen, approved in the US – new treatment for multiple sclerosis

March 29, 2013 | By Márcio Barra

The big news yesterday was that Tecfidera (dimethyl fumarate) from Biogen Idec Ltd, won approval in the US as a first-line oral treatment for people with relapsing forms of MS. Tecfidera was just approved last Friday by EMA, and the US approval is sure to thrill Biogen.

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.

Biogen has already a strong MS franchise in the US, including the blockbusters Avonex (interferon beta-1a), and Tysabri (natalizumab). Tecfidera is expected to join the ranks of these blockbusters and go face to face with its oral rivals, Novartis’ MS pill Gilenya (fingolimod) and Aubagio, a once-a-day tablet from Sanofi (this one was approved too last week by EMA alongside Tecfidera, although EMA declined to give it a “new active substance” designation, paving the way for generic competition. It is approved in the US since September last year)

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This drug, due its improved safety profile versus Gilenya and Aubagio, is widely expected to become the No. 1 oral treatment for Multiple Sclerosis, with annual sales topping $3 billion if it gains the trust of MS physicians. Aubagio carries the risk of liver injury, birth defects and comes along with a boxed warning. As to Gilenya, although first to market, it 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, and these tended to get better over time without stopping the drug.

As for the price, it will be priced at $54,900 per patient per year, cheaper than Gilenya ($60,000 per patient per year), but more expensive than Aubagio ($48,000 per year). Like all MS treatments, patient assistance programs are in place to help pay for the drug when its price is not covered by insurance.



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