Roche hit as FDA seeks more data on arthritis drug

Thu Dec 4, 2008 11:04pm GMT
 
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* U.S. regulators ask for more data on Actemra

* Do not require more clinical studies

* Roche hepatitis C drug approved in Europe

* Stock falls 1.9 pct, underperforms sector index

(Adds analyst comment, updates shares)

By Katie Reid

ZURICH (Reuters) - U.S. approval for Roche Holding AG's (ROG.VX) Actemra has been delayed further after regulators asked for more non-clinical data on the potential blockbuster rheumatoid arthritis drug.

The Swiss group said on Thursday the Food and Drug Administration (FDA) had requested additional animal model data but had not ordered further clinical studies, and that the company would submit the required information in the third quarter of next year.

By 0900 GMT, Roche stock had fallen 1.9 percent to 165.90 Swiss francs, underperforming a 1.2 percent rise in the DJ Stoxx healthcare index .SXDP.  Continued...

 

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