Follow on Google News Industry News News By Location Country(s) Industry News
Follow on Google News | AROG's CP-868,596 Granted Orphan Drug Designation and Assigned the Generic Name CrenolanibAROG Pharmaceuticals, LLC (“AROG”) is pleased to announce that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CP-868,596 for the treatment of glioma and assigned the generic name crenolanib.
By: Susan Do “We are looking forward to aggressively developing CP-868,596 for the treatment of gliomas and other rare cancers,” said Vinay Jain, MD, Chief Executive Officer of AROG. “The orphan drug designation is an important step forward to support the development of CP-868,596.” According to the Orphan Drug Act of 1983, the orphan drug designation is granted to companies with products aimed at treating rare diseases or conditions that affects fewer than 200,000 Americans. If the company’s product is granted the orphan drug status by the FDA, the company will be eligible to receive various financial incentives, including tax credits, access to grant funding for clinical trials, accelerated FDA review and marketing exclusively after drug approval for a period of as long as seven years. Crenolanib Designated as Generic Name for CP-868,596 AROG is also pleased to announce that the United States Adopted Name Council (USANC) and the World Health Organization’ About Crenolanib (CP-868,596) Crenolanib is a potent and selective inhibitor of platelet derived growth factor receptors (PDGFR). In April 2010, AROG signed an exclusive worldwide license with Pfizer for the development and commercialization of crenolanib. Phase I single agent and Phase Ib (combination with docetaxel and axitinib) clinical trials with crenolanib have been completed. About AROG Pharmaceuticals, LLC AROG is a private, oncology-focused drug development company based in Dallas, TX. AROG’s mission is to develop novel anticancer drugs for the treatment of rare cancers with significant unmet medical need. To learn more about AROG, please visit www.arogpharma.com. End
Account Email Address Disclaimer Report Abuse
|
|