Roche has gained FDA approval for its potential blockbuster rheumatoid arthritis drug Actemra. The drug is available to patients with moderate to severe RA whose disease doesn't respond to TNF therapies. Actemra is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA.
The not-so-good news for the company is that the drug was not approved as a first-line treatment for the disease--an approval that would have significantly expanded the drug's market. "We are optimistic that working with the agency, we will be able to generate the additional data required to support approval in earlier lines of RA therapy and are committed to comprehensively characterizing both the clinical benefit and the safety of Actemra in earlier lines of therapy through our large pharmacovigilance program, including the risk management program, and ongoing clinical and post-marketing studies globally," CMO Hal Barron says in a statement.
The drug is already approved in Europe, where it's known as RoActemra. It will be available in the U.S. the week of January 18.
- see the release from Roche