FDA Accepts NDA for Aemcolo (Rifamycin SV MMX) for Travelers' Diarrhea

May 21, 2018

Cosmo Pharmaceuticals N.V. (SIX: COPN) announced on 5/21/18 that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of November 16, 2018 for its decision on the New Drug Application (NDA) for Aemcolo (Rifamycin SV MMX®) for the treatment of patients with travelers' diarrhea (TD). In October 2017, the FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo. Aries Pharmaceuticals, Inc., Cosmo's U.S. subsidiary based in San Diego, California, a specialty pharmaceutical company commercializing best-in-class gastroenterology products, will lead the commercial sales and marketing for Aemcolo, developed by Cosmo Pharmaceuticals, N.V., in the U.S.

Fast Track Designation is primarily based on data from Phase 3 clinical trials of Aemcolo in travelers' diarrhea, completed in the U.S. and EU, that demonstrated Aemcolo's superiority as compared to placebo (p-value= 0.0008) and its non-inferiority as compared to Ciprofloxacin. The Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need.

"We are pleased with the FDA's decision to Fast Track Aemcolo and potentially provide those who suffer from travelers' diarrhea with a new treatment option," said Tom Joyce, CEO of Aries Pharmaceuticals. "Travelers' diarrhea can be highly disruptive and cause significant discomfort for patients, and in some cases, it can progress to more serious conditions if not treated effectively. Aemcolo has the potential to be an excellent fit within our portfolio of novel products that address high unmet needs for physicians and patients in diagnosing and treating gastrointestinal disorders."

If approved, Aemcolo will be eligible for an additional five years of market exclusivity based on the QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections.

CP Wire

Submit an article to cafepharma's CP Wire. Click here to find out more.

current feelings about your job

Please rate how you feel about your job this moment. 1 = "I hate my job" and 7 = "I love my job"
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Fill in the blank.