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Ravidasvir for HCV added to Chinese FDA priority review list
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The Chinese Food and Drug Administration added Ascletis’ hepatitis C NS5A inhibitor ravidasvir to the list of proposed priority review to accelerate its new drug application process, according to a press release.
“We launched our first breakthrough HCV regimen 3 months ago,” Jinzi J. Wu, PhD, chairman and CEO of Ascletis, said in the release. “The priority review for ravidasvir NDA will accelerate the launch of Ascletis’ all-oral regimen. This will enable Ascletis to soon provide two breakthrough HCV treatment regimens for Chinese patients and further strengthen our leadership position as an integrated solution provider in HCV treatment in China.”
Results from a study published early in 2018 showed that ravidasvir in combination with Ganovo (ritonavir-boosted danoprevir, Asceltis) provided 100% sustained virologic response among patients with HCV and baseline NS5A resistance mutations after 12 weeks of treatment.
The WHO also recently added ravidasvir to the list of recommended therapies in their Guidelines for the Care and Treatment of Persons Diagnosed with Chronic Hepatitis C.
Reference: www.ascletis.com