Arguably the most highly anticipated regulatory action on this list is the FDA’s decision for Gilead’s twice-yearly lenacapavir injection for pre-exposure prophylaxis (PrEP) for HIV. The FDA is scheduled to release its decision on June 19.
Anticipating an approval, Gilead has been preparing to launch the product, engaging in what Chief Commercial Officer Johanna Mercier called “market development initiatives” on an investor call in April. “We are absolutely ready for the launch,” she said, noting that partly because of Gilead’s efforts, the U.S. PrEP market has grown 16% year-on-year.
Writing to investors on Feb. 12, Jefferies analysts noted that the HIV community appeared to be “educated” and prepared for lenacapavir, with some observers “already seeing increases in HIV doc appointments scheduling” ahead of approval.
Gilead is backing lenacapavir’s application with data from the Phase III PURPOSE 1 and PURPOSE 2 studies. PURPOSE 1, which focused on cisgender women, demonstrated a 100% efficacy rate for preventing HIV infection. PURPOSE 2, meanwhile, enrolled a more diverse population of cisgender men, transgender men, transgender women and nonbinary individuals who have sex with partners assigned male at birth. Results showed that twice-yearly lenacapavir cut HIV incidence by 96%.
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