Makers of once-every-six-months HIV treatment file for FDA approval

Patient receiving an injection
Photo: Wikimedia Commons

Pharma giant Gilead has applied for FDA approval for a new HIV treatment that only needs to be injected every six months.

The treatment is called Lenacapavir. If approved, it would be the first so-called HIV capsid inhibitor that gets approval. It has been developed specifically for those with HIV who have tried other treatments and have developed resistance to some of their medications.

In trials, when Lenacapavir was given to these patients, the vast majority saw their viral load fall back to undetectable levels.

“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.”

Related: Carl Schmid on the “game-changer” innovations to help end 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 multi-drug resistance in combination with other antiretroviral drugs”.

In other words, because the…

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