FDA nod for second Brexafemme indication

The US Food and Drug Administration (FDA) has approved a second indication for Brexafemme (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).

The oral antifungal is marketed by US biotech Scynexis (Nasdaq: SCYX), whose shares rose 4.3% to $2.20 in after-hours trading on Monday.

In June last year, the FDA approved the drug for oral use in patients with vulvovaginal candidiasis (VVC) and the drug was launched in the USA in September that year. Scynexis has previously forecast that peak sales of the drug could reach between $400 million and $600 million.