The submission received priority review and received a target regulatory decision date of November 30, 2022.
If approved for this second indication, BREXAFEMME would be the first and only treatment approved in the United States for the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent VVC.
Regulatory submission for label extension is supported by positive data from the pivotal Phase 3 CANDLE study in which ibrexafungerp successfully achieved statistically significant superiority over placebo for both primary and secondary endpoints of the study.
SCYNEXIS will present the results of the CANDLE study this week at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) to be held in Boston, August 4-6, 2022.
JERSEY CITY, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to beat and prevent hard-to-treat and drug-resistant infections, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s submission of a supplemental new drug application (sNDA) to extend the label of BREXAFEMME® (ibrexafungerp tablets) to include prevention of recurrent vulvovaginal candidiasis (RVVC). The FDA granted priority review of the submission and set the Prescription Drug User Fee Act (PDUFA) target decision date of November 30, 2022.
If approved for this second indication, BREXAFEMME, an oral non-azole treatment, would be the first and only product approved in the United States for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of CVRV, defined as three or more infections in a 12-month period.
“The FDA’s acceptance of this submission is great news for patients, and it brings us one step closer to our vision of addressing significant unmet women’s health needs,” said Marco Taglietti, MD, President and CEO of SCYNEXIS. “Our pivotal CANDLE study was the basis of the sNDA submission, and we look forward to presenting the details of this data to the medical community.”
SCYNEXIS will present results from the CANDLE study this week at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) to be held in Boston August 4-6, 2022.
Ibrexafungerp is designated by the FDA as a Qualified Infectious Disease Product (QIDP), allowing for a six-month priority review.
About BREXAFEMME® (ibrexafungerp tablets)
BREXAFEMME is a new oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, inhibition of glucan synthase, is fungicidal against candidiasis species, which means it kills fungal cells. BREXAFEMME was approved by the United States Food and Drug Administration (FDA) on June 1, 2021. The approval was supported by positive results from two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies ( VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with CVV. BREXAFEMME represents the first drug approved in a new antifungal class in more than 20 years and is the first and only treatment for vaginal yeast infections that is both oral and non-azole.
BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult pediatric and post-menarchic women with vulvovaginal candidiasis (VVC).
DOSAGE AND ADMINISTRATION
The recommended dose of BREXAFEMME is 300 mg (two 150 mg tablets) twice daily for one day, for a total treatment dose of 600 mg. BREXAFEMME can be taken with or without food.
IMPORTANT SAFETY INFORMATION
BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
Administration of BREXAFEMME during pregnancy may cause fetal harm according to animal studies. Before starting treatment, check pregnancy status in women of childbearing potential and advise them to use effective contraception during treatment
When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice daily for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided.
The most frequently observed adverse reactions in clinical trials (incidence ≥ 2%) were diarrhoea, nausea, abdominal pain, dizziness and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, visit www.brexafemme.com. Please click here for prescribing information.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients around the world overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS scientists are developing the company’s lead asset, ibrexafungerp, as a broad-spectrum systemic antifungal for multiple fungal indications in community and hospital settings. SCYNEXIS has launched its first commercial product in the United States, BREXAFEMME® (ibrexafungerp tablets). The U.S. Food and Drug Administration (FDA) approved BREXAFEMME on June 1, 2021. In addition, clinical investigation and development of oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC) and treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. For more information, visit www.scynexis.com.
Statements in this press release regarding expected future events or results are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the filing progress of an sNDA for RVVC, from ibrexafungerp, its potential use by physicians and patients in multiple healthcare settings. Because these statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks inherent in the ability of SCYNEXIS to successfully develop and obtain FDA approval for ibrexafungerp for additional indications, including the IV formulation of ibrexafungerp; unexpected delays may occur in the timing of FDA’s acceptance of an NDA submission; the expected costs of the studies and the date on which they could begin or end; SCYNEXIS’ need for additional financial resources; and SCYNEXIS’ reliance on third parties to conduct SCYNEXIS’ clinical studies and market its products. These and other risks are described in more detail in SCYNEXIS’ filings with the Securities and Exchange Commission, including, without limitation, its most recent Annual Report on Form 10-K and its Quarterly Report on Form 10. -Q, including in each case under the caption “Risk Factors,” and in other documents subsequently filed or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made.SCYNEXIS undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.