Withdrawn application: Vivjoa, Oteseconazole, Date of withdrawal: 24/08/2023, Initial authorisation
The company presented the results from three main studies. The first two studies were similar; they were each carried out in around 330 women with recurrent vulvovaginal candidiasis who were experiencing an acute episode of vulvovaginal candidiasis at the start of the study.
During the first week, all women received 3 doses of fluconazole, another antifungal medicine. After 14 days, women whose acute episode of vulvovaginal candidiasis had resolved then received either Vivjoa or placebo (a dummy treatment) for 12 weeks. The main measure of effectiveness was the number of women who had one or more episode of acute vulvovaginal candidiasis during the 48 weeks after starting Vivjoa or placebo.
The third study involved 219 women with an episode of acute vulvovaginal candidiasis. The first week, they received either 2 doses of Vivjoa or 3 doses of fluconazole. After 14 days, women whose acute episode of vulvovaginal candidiasis had resolved then received either Vivjoa (if they initially received Vivjoa) or placebo (if they initially received fluconazole) for 11 weeks. The main measure of effectiveness was the number of people who had one or more episodes of acute vulvovaginal candidiasis during the 50 weeks after starting Vivjoa or fluconazole. The study also looked at the number of women whose acute vulvovaginal candidiasis at the start of the study resolved in the first 14 days.
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