Novartis Receives FDA Approval For Extavia

Novartis has received FDA approval for Extavia (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from the company.

Extavia is approved by FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease, as shown by magnetic resonance imaging (MRI).

The company said that Extavia will be available to patients in the US this fall. Along with their prescription for Extavia, patients will be given access to a support program including a nurse helpline, one-on-one injection training and reimbursement support services.

Interferon beta-1b has been shown to reduce annualized relapse rates by 34%, with patients nearly twice as likely to remain relapse-free for more than two years compared to those receiving placebo (31% vs. 16%).

In addition, treatment with interferon beta-1b may slow disease progression. After two years, almost three-quarters of patients who experienced a single episode of neurological disease lasting 24 hours or more, did not progress to clinically definite MS.

Novartis gained the rights to seek approval for its own branded version of interferon beta-1b through agreements with Bayer Schering, the company that markets Betaseron. Betaseron is marketed under the name of Betaferon outside the US.

Joe Jimenez, CEO of Novartis’ Pharmaceuticals division, said: We are committed to providing new approaches to MS care, and the FDA approval of Extavia marks the beginning of our long-term commitment to the MS community in the US.