Biotech Values

[DewDiligence]

FDA approves Roche’s Actemra for RA:

http://finance.yahoo.com/news/FDA-Approves-ACTEMRA-bw-1849976287.html?x=0&.v=1

Actemra has a notable history insofar as an FDA advisory panel endorsed it by a 10-1 vote, but the FDA rejected the BLA anyhow in Dec 2008 (#msg-33965815). Actemra thus belongs to an exclusive set of drugs that includes PFE’s Fablyn/Oporia (lasofoxifene), Schering-Plough’s Bridion (sugammadex), and DNDN’s Provenge; to date, Actemra is the only one of these four to obtain FDA approval.

Actemra adds to the growing set of non-anti-TNF biologics approved for RA, and it will presumably compete with Orencia and Rituxan for use in the second-line biologic setting, which is typically the third-line setting overall.

The charts in #msg-39417561, though somewhat out of date, are helpful for gauging the size of the addressable market.