GlaxoSmithKline's long-acting HIV drug nabs FDA priority review as a preventative option

GlaxoSmithKline’s long-acting HIV drug cabotegravir is already challenging market leaders as part of an approved treatment regimen. Now, the medicine is a step closer to being a potential preventative option.

On Tuesday, cabotegravir scored an FDA priority review designation for HIV pre-exposure prophylaxis (PrEP), setting it up for a decision from the agency by January 24. If approved, it'd be the first long-acting PrEP drug and would challenge big-selling medicines from Gilead Sciences.

In combination with Johnson & Johnson’s rilpirivine, cabotegravir won an FDA approval to treat HIV in January. Known commercially as Cabenuva and injected every other month, the new med gives patients an alternative to daily pills.

GlaxoSmithKline's ViiV Healthcare developed the drug and started its rolling submission for the PrEP use back in May. The FDA identified cabotegravir as a breakthrough therapy in PrEP last November. 

Before its FDA approval, the drug was slow to the finish line because of manufacturing problems, which delayed its approval by more than a year. But as a preventative option, cabotegravir appears to be speeding toward a green light.

RELATED: More threat to Gilead's HIV business? GlaxoSmithKline touts long-acting injectable PrEP win against Truvada

The optimism for cabotegravir in PrEP comes from two late-stage trials of men who have sex with men, transgender women and cisgender women. Both studies were halted early by independent data safety monitoring boards after cabotegravir showed superior efficacy to Gilead’s daily pill Truvada in both men and women.

“In the United States, fewer than 25% of those who could benefit from PrEP are currently taking it, which points to the need for additional HIV prevention options,” ViiV R&D chief Kim Smith said in a statement. “We believe new options like investigational cabotegravir will help play a significant role in our collective efforts to end the HIV epidemic.” 

RELATED: GSK's long-acting HIV injectable, Cabenuva, finally snags its FDA green light

GSK's cabotegravir represents a threat to Gilead's oral PrEP drugs Truvada and Descovy. After Truvada lost U.S. exclusivity last year, sales for that med crashed 72% in the second quarter to $108 million. Meanwhile, as demand grows for newer option Descovy, that drug posted a 4% sales increase to $435 million in the second quarter. 

For its part, Cabenuva is in early launch stages and generated just £4 million in the second quarter.

ViiV Healthcare is a joint venture between majority owner GSK, plus Pfizer and Shionogi.