With FDA Approved PrEP Injectable Are Our Pill Popping Days Numbered?

Savas Abadsidis December 21, 2021

Now that the Food and Drug Administration has approved ViiV healthcare’s HIV PrEP injectable Apretude, can the end of the pill popping days of Gilead’s Truvada and Descovy be far behind?

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Fierce Pharma: On Monday, the FDA blessed GSK’s Apretude, or cabotegravir, to reduce the risk of sexually acquired HIV. The endorsement provides users the first long-acting injected option in the pre-exposure prophylaxis (PrEP) setting.

With that, Apretude will go up against Gilead’s well-established Truvada and its generic, plus the California biotech’s newer Descovy. Unlike those daily pills, Apretude is administered once every two months after the loading doses. The drug has shown stellar efficacy in two phase 3 trials, topping Gilead’s daily pill Truvada in both men and women at preventing HIV infections.
ViiV is offering Apretude at the wholesale acquisition cost of $3,700 per vial, a company spokesperson told Fierce Pharma. Given its bimonthly dosing, Apretude costs about the same or less than branded oral PrEP options.
Before the PrEP nod, cabotegravir and Johnson & Johnson’s rilpivirine won an FDA go-ahead in January as Cabenuva to treat patients infected with HIV. Citing strong patient demand for long-acting options in HIV, GSK thinks the cabotegravir franchise could reach over £2 billion in sales in 2026.
That’s an ambitious goal considering Cabenuva only sold £18 million in the first nine months of 2021. But ViiV believes the franchise is only beginning to take off.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.”