Scynexis (SCYX) Announces Receipt of FDA Orphan Drug Designation for SCY-078 as Aspergillus Infections Treatment
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Drug development company SCYNEXIS, Inc. (Nasdaq: SCYX) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company’s novel triterpenoid broad-spectrum antifungal agent, SCY-078, for the treatment of invasive Aspergillus infections.
The orphan drug designation of SCY-078 provides seven years of market exclusivity in the U.S. following FDA approval of an NDA for the orphan designated indication. This is the second U.S. orphan designation received for SCY-078. Earlier this year, the Company announced that SCY-078 received orphan drug designation for the treatment of invasive Candida infections, including candidemia. The Company was previously granted Qualified Infectious Disease Product (QIDP) designation for both the IV and oral formulations of SCY-078, which provides an additional five years of exclusivity. Together, these designations provide SCYNEXIS with a potential 12 years of market exclusivity in the U.S. upon FDA approval.
"The FDA's decision to grant SCY-078 orphan drug designation for invasive Aspergillus infections is another important milestone in the development of our lead compound recognizing the broad antifungal spectrum of this novel antifungal agent. We believe SCY-078 has the potential to be a unique treatment option for patients with acute and chronic fungal infections caused by Aspergillus," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "SCY-078 has clinically-relevant attributes such as high tissue penetration and distribution, reduced risk for drug-drug interactions, activity against azole-resistant pathogens and versatile administration with both oral and IV formulations. If approved, SCY-078 would currently be the only alternative to azoles to treat invasive Aspergillus infections (including azole-resistant strains), with the flexibility of both oral and IV formulations."
In the U.S., under the Orphan Drug Act, the FDA's Office of Orphan Products Development grants orphan drug designation to products intended to treat rare diseases or conditions, which are defined by the FDA as those affecting fewer than 200,000 people in the U.S.. In addition to the potential U.S. market exclusivity in the specified indication, if SCYNEXIS complies with certain FDA requirements, the designation provides several benefits and incentives, including tax credits related to qualified clinical trial expenses, eligibility for orphan drug grants, and an exemption from FDA application fees.
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