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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ViiV unblinded the Phase III study on positive data, and it plans to pursue approval in H1 2021.
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.