Bayer, Onyx Pharmaceuticals Announce FDA Priority Review Designation of Nexavar
Bayer HealthCare (OTC: BAYRY) and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation to the supplemental New Drug Application (sNDA) for the oral multi-kinase inhibitor Nexavar® (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. The FDA grants priority review status to drug candidates that may offer a significant improvement in treatment over existing options. The Prescription Drug User Fee Act (PDUFA) date for completion of review by the FDA of the sNDA is December 25, 2013.
"We are very pleased that the FDA has chosen to grant Priority Review to sorafenib," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "This is an important milestone for sorafenib and the designation highlights the urgent need for new treatments for patients with this type of thyroid cancer who have limited or no treatment options."
"Sorafenib could offer an FDA-approved treatment option for patients with this type of thyroid cancer," said Pablo J. Cagnoni, M.D., Executive Vice President, Global Research & Development and Technical Operations,