Biotech Values

[mcbio]

Re: FDA Safety Review of GnRH agonists/NBIX

FDA Opens Safety Review of Lupron and Related Drugs for Prostate Cancer

[Further details are available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209842.htm .]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210549.htm

›FDA NEWS RELEASE
May 3, 2010

* Preliminary review suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists

Gonadotropin-Releasing Hormone (GnRH) agonists, a class of medications primarily used to treat men with prostate cancer, have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men treated with one of the medications, according to a preliminary and ongoing analysis of several studies by the U.S. Food and Drug Administration.

Just curious what impact, if any, this will have on NBIX and its ongoing development of elagolix for endometriosis. Note that elagolix is apparently a GnRH antagonist as opposed to agonist so I presume that may add a level of separation from what is discussed here. Maybe not though. If not, is this potentially bearish news for the elagolix program? E.g., perhaps the FDA will place even greater emphasis on safety in the upcoming Phase 3 trials requiring longer trials with more patients and, ultimately, perhaps this makes ultimate FDA approval more difficult given what might be a higher safety hurdle. Any reason for concerns here?