FDA approves Roche’s Actemra

pharmafile | January 11, 2010 | News story | Sales and Marketing Actemra, RoActemra, Roche, US, rheumatoid arthritis 

Roche’s Actemra has been approved in the US for the treatment of moderately to severely active rheumatoid arthritis (RA) and will be available next week.

The US Food and Drug Administration (FDA) said it can be used in patients who have had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies.

The drug may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).

Roche had resubmitted its application in July to answer some questions raised about manufacturing and labelling in its first filing.

Actemra (tocilizumab) is the first of the new class of interleukin-6 receptor-inhibiting monoclonal antibodies to come to market.

“The FDA approval of Actemra marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease,” said Roche and Genentech chief medical officer Hal Barron.

“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.”

The drug, known as RoActemra outside the US, has been available in Europe for a year but will need to present a stronger case to gain approval for use on the NHS.

NICE’s preliminary verdict last October said that, at more than £9,000 per year for a patient of average weight, it was not a cost-effective option.

The medicines watchdog is not scheduled to make a final decision until May this year.

RA is a chronic, progressive disease which makes joints and surrounding tissue painfully inflamed, sometimes causing irreversible joint destruction and wider physical complications.

IL-6 is one of the key cytokines, or proteins, that are involved in causing the inflammation and Actemra is the first drug designed to specifically inhibit its activity.

Five phase III studies involving 4,000 patients have showed that the drug reduces the signs and symptoms of RA, regardless of previous therapy, compared with DMARDs alone.

In addition to the EU and US, it is approved in Mexico, India, Brazil, Switzerland and Australia.

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