EMEA approves sale of Roche's RA blockbuster

Roche has won final European approval to market RoActemra, a potential new blockbuster therapy for rheumatoid arthritis. Last month the FDA said it would need to examine additional data from animal studies before it could extend an approval on the drug, which is called Actemra in the U.S. And analysts in Europe were quick to highlight the quickened regulatory pace on the continent.

"The EMEA green light is a clear sign that the FDA is overly cautious. Roche however will need to conduct the trial and then file the data. We expect U.S. approval in 2010," Vontobel analyst Andrew Weiss told the Guardian. The drug is already approved in Japan.

The news buoyed Roche's share price buoyed as other health stocks declined. "After investors tried to play the fallen angels at the start of the New Year, defensive sectors such as pharma are now en vogue again," analysts at Julius Baer said in a note about Roche.

Actemra represents a significant new advance in the fight against rheumatoid arthritis. It is an anti-interleukin-6 receptor antibody, which has a different mechanism of action than the anti-tumor necrosis factor therapies on the market now.

- read the report in The Guardian

Related Articles:
Advisory Panel recommends Actemra to FDA
Roche posts new data backing Actemra for RA
Roche to hit top in cancer sales by 2012
Roche drug touted at rheumatology confab