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Recurrent vulvovaginal candidiasis (RVVC, image source: cliniexpert.
com)
July 28, 2021/Bio Valley BIOON/ --Mycovia Pharmaceuticals recently announced that the U.
S.
Food and Drug Administration (FDA) has accepted the new drug application (NDA) for oteseconazole (VT-1161) and granted priority review
.
Oteseconazole is an oral antifungal drug used to treat recurrent vulvovaginal candidiasis (RVVC)
The FDA has designated the NDA’s "Prescription Drug User Charges Act" (PDUFA) target action date of January 27, 2022
.
Previously, the FDA has granted oteseconazole Qualified Infectious Disease Product Designation (QIDP) and Fast Track Designation (FTD)
RVVC, also known as chronic yeast infection, is a disease different from vulvovaginal candidiasis (VVC).
It is defined as an acute attack of symptomatic yeast infections three or more times a year.
The main symptoms include vaginal itching, burning, irritation and Inflammation
.
Some women may experience abnormal vaginal discharge, painful intercourse, or painful urination, causing various but often severe discomfort and pain
Ooteseconazole (VT-1161) is an orally administered fungal CYP51 inhibitor developed by Mycovia for the treatment of RVVC and onychomycosis
.
Compared with currently available antifungal drugs, oteseconazole has higher selectivity, fewer side effects and higher efficacy
The chemical structure of oteseconazole (VT-1161) (picture source: medchemexpress.
com)
Oteseconazole NDA is based on the positive results of 3 phase 3 clinical trials: 2 global VIOLET studies and 1 ultraVIOLET study in the United States, including more than 870 patients in 232 clinical locations in 11 countries
.
Both VIOLET studies reached the primary and key secondary endpoints
Patrick Jordan, CEO of Mycovia Pharmaceuticals, said: "RVVC is a disease different from yeast infections (VVC), so a different treatment is required
.
Studies have shown that fluconazole, the standard treatment for VVC, is an initial treatment for VVC.
The effective rate of onset is more than 90%, but in the study of RVVC patients, more than 50% of women relapsed after the interruption of maintenance treatment
Original source: Mycovia Pharmaceuticals Announces US FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
