Biotech Values

[DewDiligence]

Yet another case where FDA overruled advisory panel. PFE’s
Lasofoxifene has a tortured history: it was rejected by the
FDA in 2005 but was seemingly resurrected when an advisory
panel voted 9-3 to approve the drug in Sep 2008. PFE’s PR
does not assert that no new clinical trials are needed, which
almost surely means that they are.

http://finance.yahoo.com/news/Pfizer-Receives-FDA-Complete-bw-14088243.html

›Pfizer Receives FDA Complete Response Letter for Lasofoxifene

Friday January 16, 2009, 5:05 pm EST

NEW YORK--(BUSINESS WIRE)--Pfizer Inc said today it has received a complete response letter from the U.S. Food and Drug Administration (FDA) asking for additional information on the company’s application for lasofoxifene. The investigational compound is currently under review for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Pfizer is reviewing the letter and will work with FDA to determine the appropriate next steps regarding the company’s application. [The salient point here is that there’s no assertion regarding the lack of a need for new trials.]

Pfizer submitted the current application for lasofoxifene on December 18, 2007. On September 8, 2008, an FDA scientific advisory panel voted 9-3 (with one abstention) that there is a population of postmenopausal women with osteoporosis in which the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion on December 18, 2008, recommending marketing authorization for lasofoxifene. The CHMP’s opinion will be reviewed by the European Commission, which has authority to approve medicines for the European Union.

About Lasofoxifene

Lasofoxifene is a selective estrogen receptor modulator, or SERM, in the same chemical class as raloxifene [Evista from LLY]. With its high affinity for estrogen receptors, lasofoxifene acts as an agonist in bone and as an antagonist in the breast. Thus, it modulates the estrogen receptor in a different manner than estrogen, which accounts for the effects of lasofoxifene observed in multiple target tissues.‹