Japan's Takeda gets U.S. FDA priority review for ixazomib

Japan's Takeda Pharmaceutical has won U.S. FDA Priority Review status for its New Drug Application for ixazomib, the company said in a release. "We are encouraged that both the U.S. and European regulatory bodies have determined that the ixazomib applications qualify for an expedited review, underscoring the importance of new treatment options for patients with relapsed/refractory multiple myeloma," said Melody Brown, vice president of Regulatory Affairs. The company submitted the application in July. In the May earnings release, Takeda Pharmaceuticals CEO and President Christophe Weber noted Phase III interim results for ixazomib were in, building slightly on an analysis released in February that showed ixazomib beat out a placebo in extending progression-free survival for multiple myeloma sufferers who have failed prior treatments. The FDA decision on priority puts the candidate in a better position to enter an expanding market for multiple myeloma drugs as the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. The market for such drugs is estimated at nearly $9 billion by 2021, GBI Research says. Release