Roche nabs coveted FDA OK for Actemra

Roche now has the Actemra indication it wanted in the first place, or close to it. The company says FDA blessed the rheumatoid arthritis drug for inhibiting joint damage and improving function in moderate to severe forms of the disease, used in combination with the standard drug methotrexate, in patients who haven't fully responded to other drugs.

Actemra won its first U.S. approval last year, as a second-line treatment for moderate to severe RA. It's a new type of RA remedy that blocks a protein called interleukin-6. Winning the new indication gives Actemra new ammo for competing with with the TNF-alpha inhibitors, an established class that includes Amgen and Pfizer's Enbrel, and Johnson & Johnson and Merck's Remicade.

Those drugs are among the world's top-selling medications with more than $6 billion in sales each. Abbott Laboratories' Humira also brings in $4 billion-plus. If Actemra can manage to steal even a small fraction of market share from those drugs, then Roche could reap a billion-dollar windfall. The company is all but counting on it, and so are analysts, who have predicted peak sales of almost $5 billion.

- get the release from Roche
- see the Bloomberg news
- read the story in the San Francisco Business Times

Clarification: The original article did not specify that the new Actemra indication is for patients who haven't fully responded to first-line therapy.