The US Food and Drug Administration has given Novartis approval to market its MS medication, Extavia, for use in people with early and relapsing 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 MRI.
A form of interferon beta-1b, Extavia is a copy of Bayer’s Betaseron. Novartis gained the rights to seek approval for its own branded version of interferon beta-1b through agreements with Bayer, and the company is paying royalties to Bayer. Extavia is already available in 12 European Union countries.
Extavia is expected to be available in the US sometime this fall and it will be marketed with a support package including access to a nurse help-line, one-on-one injection training, and reimbursement support services. Novartis will also make auto injectors available to Extavia users.
Novartis is counting on Extavia to help the company establish a presence in the MS community, paving the way for the introduction of its MS oral drug FTY720. Novartis has said it plans to submit FTY720 for US and European regulatory approval by the end of this year.