Exceeding analyst expectations for a failure, the FDA's Oncologic Drug Advisory Committee voted 12-1 against an expanded use for Amgen's denosumab drug Xgeva. The pharma company wanted the greenlight for the drug as a preventive measure for men with castration-resistant prostate cancer, but whose cancer has not spread to the bones. A study showed the drug delayed the onset of bone tumors by just over 4 months. Xgeva is a high dose of the denosumab injection, which Amgen also markets in a lower dose as skeleton-building drug Prolia. The panel questioned the preventative value of a drug that delays cancer from spreading instead of stopping it, and was also concerned by the high rate of bone degeneration among patients with extended exposure to the drug.
Despite analyst failure expectations, the defeat still held a degree of surprise. "FDA's ODAC panel 12-1 vote against recommending approval of Xgeva sBlA was more negative than we had expected," Jefferies analyst Eun K. Yang wrote in a research note. The no votes were from the panel's 12 physicians. The lone yes was from the patient advocate, the Associated Press reported. The FDA is not bound by the panel's decision and can still support an expanded use of the drug.
Greece is cranking up its austerity measures, and pharmaceutical purchases are far from exempt, reported PharmaTimes. Although Greece expects to outspend the European Union's recommended 2.1 billion euro cap by 33%, Greece's health minister said the country is in slim-down mode. The projected 2.8 billion is a drop from 2011's 4.1 billion spend, according to PharmaTimes. The health minister estimated the country tosses out 1 billion worth of unnecessary prescriptions each year. The cutbacks have global repercussions. Merck's February earnings reports specifically called out European austerity measures as a factor that affected its bottom line.