A potential blockbuster to treat a form of rheumatoid arthritis has been approved by the US Food and Drug Administration (FDA).
Actemra was approved only to treat moderately to severely active rheumatoid arthritis where the disease does not respond to other therapies blocking the “tumour necrosis factor” which plays a role in inflammation.
Drug company Roche Holding AG said it is hopeful of generating extra data needed to support approval in earlier lines of rheumatoid arthritis therapy .
The Basel-based drug firm said it is committed to “comprehensively characterizing both the clinical benefit and the safety of Actemra in earlier lines of therapy”, said Roche executive Hal Barron.
Approval by the FDA followed resubmission of documents for Actemra.
These included a proposed risk evaluation and strategy to ensure that health care professionals prescribe and administer the drug correctly, and also that patients understand both the benefits and the known and potential risks associated with the drug.
Actemra is considered by analysts to have blockbuster potential with possible peak sales of $1 billion (£623,823,000) but analysts’ enthusiasm has waned since the drug was linked to severe side effects in Japan.
Copyright Press Association 2010