Treatment for rare, severe hepatitis nears US regulatory submission
Gilead Sciences (Nasdaq: GILD) has announced interim results from Phase IIb and Phase III trials evaluating Hepcludex (bulevirtide), a first-in-class treatment for chronic hepatitis delta virus (HDV).
The findings support the safety and efficacy profile of the therapy, and are being outlined in a late-breaker at the International Liver Congress (ILC) 2021.
Originally developed by German biotech MYR Pharmaceuticals, the treatment secured conditional approval in Europe in August 2020, and will be submitted for approval in the USA later this year.
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