dm+d

Unassigned

New Medicines

VivjoaRecurrent vulvovaginal candidiasis - treatment and prevention

Information

Vivjoa
New molecular entity
Gedeon Richter
Mycovia Pharmaceuticals

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Approved (Licensed)
Jun 22Has been filed in EU via centralised procedure, for treatment and prevention of recurrent vulvovaginal candidiasis (RVVC) including the acute episodes of RVVC in adult women [12, 13].
Apr 22Approved in US for US FDA treatment of recurrent vulvovaginal candidiasis. Mycovia plan to launch Vivjoa Q2 22 [10].
Nov 21PIII trial completed and data will support an NDA in China for oteseconazole. The US FDA have set a target action date of January 2022. Pending FDA approval, US launch is planned in early 2022. [9]
Jun 21Filed in US [8]
Nov 20Mycovia plan to file NDA with US FDA H1 2021, with fast track status. Gideon Richter has an exclusive license to commercialise oteseconazole in Europe [5].
Oct 16Granted Qualified Infectious Disease Product (QIDP) and Fast-Track designations by US FDA. [9]

Category

14α-demethylase (CYP51) inhibiitor
About 8% of women suffer recurrent vulvovaginal candidiasis (RVVC) [1].
Recurrent vulvovaginal candidiasis - treatment and prevention
Oral

Trial or other data

Jul 22 In VIOLET RCT (n=656), oral oteseconazole (150mg/d for 7 days then once weekly for 11 weeks), was effective in preventing acute vulvovaginal candidiasis (VVC) recurrence and treating recurrent VVC through week 48 vs. placebo in CL-011 and CL-012 trials [14].
Jun 22Mycovia announce positive results from VIOLET extension study (n=71); 85% of patients completed 96 weeks without a recurrent vulvovaginal candidiasis episode. Average time without recurrence was 92 weeks [11].
Jan 21Mycovia announce PIII ultraVIOLET study (n=220) met all primary and secondary endpoints. In women treated with oteseconazole recurrence rate of VVC was 5.1% vs. 42.2% with fluconazole to placebo (p <0.001). Oteseconazole was non-inferior to fluconazole in the resolution of signs and symptoms at day 14 [7].
Dec 20Mycovia announce PIII VIOLET studies achieved primary endpoint of proportion of subjects with one or more culture-verified acute vulvovaginal candidiasis (VVC) episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population [6].
Feb 19PIII ultraVIOLET study (NCT03840616) in patients with RVVC starts in US. During part 1 of the study, participants will either take 150mg VT-1161 orally once daily for 2 days or fluconazole 150mg for 3 sequential doses at 72 hour intervals. During part two they will take VT-1161 or placebo once weekly for 11 weeks starting on day 14 [4].
Jun 18Two PIII VIOLET trials (NCT03561701, NCT03562156) to evaluate efficacy and safety of VT-1161 150mg oral capsule in patients aged ≥12 years with RVVC start in US [2,3].