Roche hit with major delay on Actemra approval

Roche has been handed a major setback with today's announcement that the FDA is demanding a new animal trial along with more information on Actemra [1], a rheumatoid arthritis drug and one of its brightest late-stage prospects. Analysts expect a delay of at least 18 months before Roche can get a green light to start marketing the drug. Roche says it can resubmit its application in the third quarter of 2009.

One analyst in Switzerland says that Roche isn't likely to start selling Actemra until 2010. That will cost Roche billions of dollars in lost sales. Dow Jones notes that most analysts expect Actemra to earn around $2 billion a year.

Roche has had better luck with Actemra outside the United States. Swiss officials approved the drug this week. It's already being sold in Japan and European experts have backed Roche's application [2].

- here's Roche's release [3]
- read the report [4] from Dow Jones

ALSO: The European Commission has approved a new use of Roche's Pegasys. Release [5] | Report [6]

Related Articles:
Roche boasts new data supporting Actemra [7]
FDA delays Roche's blockbuster Actemra [1]
Roche drug touted at rheumatology confab [8]
FDA staffers say Actemra works against RA [2]