SCYNEXIS Confirms that BREXAFEMME® (ibrexafungerp tablets) Qualifies for 10 Years of Regulatory Exclusivity for Vaginal Yeast Infections
JERSEY CITY, N.J., June 09, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) granted BREXAFEMME (ibrexafungerp tablets), five years of exclusivity extension under the Generating Antibiotic Incentives Now (GAIN) Act. This exclusivity will be added to any other applicable exclusivity periods, such as the five years of new chemical entity (NCE) exclusivity, for a combined ten-year period of regulatory exclusivity. BREXAFEMME is also protected by multiple patents, including a composition-of-matter patent covering the ibrexafungerp molecule. With patent term extension, this patent is expected to expire in 2035, providing 14 years of protection from generic competitors in the U.S.
“With our first FDA approval behind us, we are very pleased to receive confirmation of BREXAFEMME’s five years of GAIN Act exclusivity for the treatment of vulvovaginal candidiasis,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We believe BREXAFEMME is an important treatment option to help patients with often resistant fungal infections and we look forward to educating the healthcare community about the availability of this exciting new product. We will also continue to work hard to fully leverage this regulatory exclusivity and our long patent protection to advance our pipeline of ibrexafungerp indications. Our vision is to create a long-lasting antifungal franchise in both hospital and community settings. We will provide a more comprehensive update on our VVC commercial plans on June 29th.”
As a novel antifungal designed to treat serious and life-threatening infections, ibrexafungerp benefitted from Qualified Infectious Disease Product (QIDP) designation, which made it eligible to receive the GAIN Act exclusivity. This act was passed in 2012 for the purpose of stimulating the development and approval of new antibiotic and antifungal drugs.
About Vulvovaginal Candidiasis
Currently approved treatments for VVC include BREXAFEMME (ibrexafungerp tablets), several topical antifungals, and oral fluconazole, which is the only other orally administered antifungal approved for the treatment of VVC in the U.S. and which has typically accounted for over 90% of the prescriptions written for this condition eery year.
About BREXAFEMME® (ibrexafungerp tablets), for oral use
Please click here for full Prescribing Information.
Dosage and Administration
Important Safety Information
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1ca08c25-c216-4a0d-b5c3-6801b1410df9