ViiV Thinks It May Get All-Gender Approval For Cabotegravir For PrEP
Final data comparing cabotegravir to Truvada for HIV prophylaxis confirms superiority. ViiV says treatment data in women may enable an all-gender approval that eluded Gilead with Descovy.
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Prospects have improved for ViiV’s long-acting, injectable cabotegravir to be approved early for HIV prevention after a Phase III trial was stopped early due to efficacy.
With efficacy data in hand, Gilead wants to balance economic sustainability with broad availability of remdesivir for COVID-19 patients. The firm did not alter guidance on Q1 earnings call.
Advisory committee sent a clear message that pre-exposure prophylaxis studies are needed in cisgender women, but what those studies might look like, and whether the agency can exercise its statutory authorities to ensure they are conducted, is less clear.