Web Analytics Made Easy - Statcounter

Gilead applies for FDA approval for six-month HIV treatment

Share this Post:
Photo courtesy of Gilead Sciences
Photo courtesy of Gilead Sciences

The pharmaceutical mega-corporation Gilead has applied for FDA approval for a new HIV treatment that only needs to be injected once every six months.

The drug, known as lenacapavir, works differently from currently available HIV meds. If approved, it would be the first so-called HIV capsid inhibitor on the market.

Gilead says it has been developed specifically for HIV-positive patients who have used other meds and have developed resistance to some or all of them.

In clinical trials, the vast majority of patients saw their viral load fall back to undetectable levels when treated with lenacapavir.

"Lenacapavir is an important breakthrough innovation with the potential to be transformative for people living with multidrug-resistant HIV who have very limited treatment options," Gilead Chief Medical Officer Merdad Parsey, MD, PhD, said in a news release.

"The filing moves us one step closer to providing an innovative treatment option that helps to address barriers to achieving viral suppression and meet the unmet needs of people living with multidrug-resistant HIV."

In May 2019, the FDA granted breakthrough therapy designation for the development of lenacapavir for the treatment of HIV-1 infection "in heavily treatment-experienced patients with multidrug resistance in combination with other antiretroviral drugs."

Because the health of these patients was at risk and their treatment options were dwindling, the FDA gave Gilead permission to speed up the development and testing process. Subsequent clinical trials have been successful, and Gilead now wants full approval to begin marketing the drug.

Although lenacapavir was developed and is currently aimed at those with multidrug resistance, Gilead has indicated that it would look into marketing the drug to the general HIV-positive population.

In fact, Gilead said last year that it was considering trials using lenacapavir as a form of long-acting PrEP. Gilead already makes HIV and PrEP drugs Truvada and Descovy.

Earlier this year, the FDA granted approval to the first once-a-month injectable HIV treatment, Cabenuva, made by a Canadian firm. That drug is aimed at the general HIV population and is already being marketed, freeing some patients from having to adhere to a daily pill regimen.