Swiss drug giant Novartis received a boost this morning in the form of a US approval to market the multiple sclerosis therapy Extavia, its own branded version of Bayer’s interferon beta-1b drug Betaseron.

Specifically, Extavia has been cleared by the US Food and Drug Administration to treat relapsing forms of MS to cut down on the frequency of clinical exacerbations, and is also indicated for patients who have experienced a first clinical episode of MS with features consistent with the disease (as shown by magnetic resonance imaging).

According to the firm, which is allowed to sell its own branded version of the drug as per an agreement signed in 2007 with Bayer, interferon beta-1b has been the gold standard of care for the treatment of relapsing MS in the USA for more than 16 years, and with the approval of Extavia, “patients have another option with a well-established safety and efficacy profile to help manage this disease”, said Doug Jeffery, associate professor at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina.

MS is a chronic autoimmune disease in which the immune system attacks the protective myelin sheath surrounding nerve fibres, leading to problems with muscle control, strength, vision balance and mental function. It is thought that the disease affects around 400,000 patients in the US alone, and that of these more than 80% have the relapsing-remitting form of the condition.

Reducing relapses
Interferon beta-1b is able to reduce the number of relapses patients suffer annually by 34%, with patients nearly twice as likely to remain relapse-free for more than two years compared to those receiving placebo, Novarits notes. Furthermore, there is also evidence to show that the drug can, in some instances, slow down the progression of the disease, which would obviously be a huge benefit to patients.

Novartis said is it planning to make Extavia available in the US in the autumn, alongside a comprehensive support package including access to a nurse helpline, one-on-one injection training and reimbursement support services, designed to help patients to better manage their disease.

Extavia is already available in 12 European Union countries after winning the stamp of approval from the European Medicines Agency in January this year.