FDA approval of Tecfidera secures Biogen Idec’s leader status in future multiple sclerosis market.
On March 27, 2013, the FDA approved Biogen Idec’s Tecfidera (dimethyl fumarate) for the treatment of relapsing forms of multiple sclerosis. The agency’s decision on the hotly anticipated oral drug was issued 1 day ahead of its Prescription Drug User Fee Act action date and 6 days after the positive opinion provided by the EMA’s Committee for Medicinal Products for Human Use. US launch of Tecfidera will take place within the coming days.
Befitting its stellar Phase III efficacy data and benign side-effect profile, Tecfidera – formerly known as BG-12 – boasts approval for first-line use, in addition to a clean label which is free of black-box warnings or burdensome monitoring requirements. Only two warnings and precautions for lymphopenia and flushing were reported in the FDA’s press release announcing the approval. Tecfidera’s superior safety to other high-efficacy treatments such as Gilenya (fingolimod; Novartis) and Tysabri (natalizumab; Biogen Idec) prevailed over Teva’s attempt to block the FDA’s decision on the drug. Teva had filed a citizen petition which requested the FDA not to approve any new multiple sclerosis drugs until the agency had referred them to an advisory committee for evaluation. Tecfidera’s clinical efficacy also sets it apart from existing first-line treatments, with its Phase III data demonstrating that the drug can reduce annualized relapse rate by 49% compared to placebo. Moreover, Tecfidera also has a robust effect on reducing disability progression and MRI activity.
As the third oral multiple sclerosis (MS) treatment to enter the US market, after Gilenya and Aubagio (teriflunomide; Sanofi), Tecfidera will serve to expand the arsenal of treatment options available to the almost 163,000 individuals estimated to suffer from relapsing multiple sclerosis in the US. Its closest rival will be Gilenya, which has already achieved blockbuster status in just its second year on the market. Indeed, Datamonitor expects Biogen Idec to seek an annual cost of therapy for Tecfidera that is comparable to that of Gilenya, although the company will reveal pricing information in the next couple of days.
On account of its extremely strong clinical profile, Datamonitor expects Tecfidera to become the leading oral treatment option for MS and achieve blockbuster status. As the leading company operating in the MS market, Biogen will be able to leverage its existing sales and marketing force and is the ideal company to successfully commercialize Tecfidera. Biogen’s established current treatment options include Avonex (interferon beta-1a) and Tysabri, both of which are blockbuster products and are positioned separately. As an oral disease-modifying drug suitable for first-line use, Tecfidera will complement the overall franchise and serve to secure the company’s leader status in the future MS market.