A group of independent FDA advisers voted in favor of a new anti-infective from Astellas Pharma, setting the stage for a likely approval.
The agency's Anti-Infective Drugs Advisory Committee voted that the benefits of Astellas' isavuconazole, to be marketed as Cresemba, outweigh its risks. The injected drug, designed to fight fungal infections, successfully treated invasive aspergillosis and mucormycosis in its two-trial Phase III program, the company said. The two infections are common among patients undergoing chemotherapy or who have received organ transplants, according to Astellas, frequently leading to acute renal failure and death.
The panel voted 11-0 in favor of approving the drug for aspergillosis and split 8-2 with one abstention on whether to recommend it for mucormycosis. The FDA is not required to follow the votes of its advisers, though it commonly does, and the agency is expected to hand down a final decision on isavuconazole by March 8.
Astellas bought into the drug's promise back in 2010, signing a deal with Switzerland's Basilea Pharmaceutica in which it paid $86 million up front and promised about $550 million more if isavuconazole came through on its development and sales goals. Beyond aspergillosis and mucormycosis, the partners are in the midst of Phase III trials against invasive candidiasis, a lethal infection caused by Candida yeasts.
The Japanese drugmaker's embrace of antibiotics follows a trend among the world's largest drugmakers, whose history of inattention to R&D in the field is in part responsible for the current increase in demand--and market opportunity--for anti-infectives. Now, buoyed by government incentives, Big Pharma is creeping back into the space, with Merck ($MRK) trading $9.5 billion for specialist Cubist Pharmaceuticals late last year and well-funded players including of Roche ($RHHBY) and Actavis ($ACT) spending big to beef up their antibiotic pipelines.