logo
Share SHARE
FONT-SIZE Plus   Neg

FDA Has Granted Priority Review To NDA For Regorafenib, Reveals Onyx Pharma

Onyx Pharmaceuticals Inc (ONXX), a global biopharmaceutical company, and Bayer Healthcare Pharmaceuticals Inc, have, on Thursday, jointly announced that the U.S Food and Drug Administration or the FDA, has granted priority review designation to the New Drug Application, or the NDA, for the oral multi-kinase inhibitor regorafenib.

The company further stated that Bayer Healthcare had filed the NDA at the end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose disease has progressed after approved standard therapies.

The company stated that Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

Onyx Pharmaceuticals further added that the FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Furthermore, the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Alteryx, Inc., a provider of self-service data analytics software, is the latest tech company to go public in March. Alteryx said it has priced its IPO of 9 million shares of its Class A common stock at $14 per share, at the top end of its range of $12 to $14 per share. Dunkin' Donuts is bidding adieu to one of its frozen coffee beverages this summer. However, loyal fans of the decades-old menu staple have not taken kindly to the news. The coffee chain said it will discontinue its popular Coffee Coolatta beverage this summer and instead, introduce the new Frozen Dunkin' Coffee, made with coffee extract, sugar and milk. Canadian pipeline operator Enbridge Inc. said it will cut about 1,000 jobs, or six percent of its workforce, following the completion of its acquisition of Houston-based Spectra Energy Corp. The job cuts will take place across the merged company.
comments powered by Disqus
Follow RTT