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Home Industry News Roche reports no new studies needed for Actemra

Roche reports no new studies needed for Actemra

23rd September 2008

Roche has announced that it need not conduct any further clinical studies for Actemra (tocilizumab) as a treatment for adult patients with moderate to severe rheumatoid arthritis in order for the compound to gain regulatory approval.

Actemra is the first interleukin-6 receptor-inhibiting monoclonal antibody being studied in this indication.

Earlier this week, the company received a complete response letter to its biologics license application for the compound from the US Food and Drug Administration (FDA).

It said all further information requested by the regulator neither involves further studies, nor safety or efficacy issues.

The FDA has asked for additional documentation relating to the manufacture of the drug and also for final labelling.

William M Burns, chief executive officer of the pharmaceuticals division of the firm, said: “Roche is committed to making this important new therapy available to rheumatoid arthritis patients.”

He added the company would work closely with the regulator to define the path ahead for the drug and resolve any outstanding matters in the near future.

In August 2008, Chugai Pharma Manufacturing, a subsidiary of Chugai Pharmaceutical, announced an agreement with Genentech for the production of Actemra, with the drug being manufactured at the latter’s Vacaville, California plant.

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