• 6/13/2006
  • Los Angeles, CA
  • press release
  • www.tradingmarkets.com

Monday, drug manufacturer MGI Pharma Inc. revealed that the U.S. Food and Drug Administration, or FDA, has accepted its New Drug Application, or NDA, for Saforis Powder for Oral Suspension for priority review.

The regulator also kept October 12 as a Prescription Drug User Fee Act goal date for review of the company’s application for Saforis.

The Bloomington, Minnesota-based MGI Pharma’s Saforis is an investigational drug candidate for the prevention and treatment of oral mucositis in patients, who have been given mucotoxic cancer therapy.

Oral mucositis is a common side effect of mucotoxic cancer therapy and has been termed by painful ulcerations, redness and swelling in the mouth. More than 200,000 patients in the U.S. are estimated to develop significant oral mucositis every year. This included nearly 40% of patients, who are undergoing standard dose mucotoxic cancer therapy and over 75% of patients receiving high dose chemotherapy with stem cell transplantation or radiation therapy for head and neck cancer.

Studies supporting Saforis

One pivotal phase 3 trial and several supportive studies form the foundation of the Saforis NDA. The pivotal phase 3 trial of Saforis was successfully completed in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens. The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met.

Data showed that patients receiving Saforis experienced a 22% relative risk reduction of clinically significant (World Health Organization or WHO Grade 2 or higher) oral mucositis compared with placebo. Apart from this, the incidence of severe oral mucositis (WHO Grade 3 or higher) was significantly reduced in Saforis patients when compared to placebo.