Pfizer, GSK-Backed ViiV First To Get FDA Approval For HIV Shots: What You Need To Know

In a first, a monthly injectable HIV drug made by a GlaxoSmithKline plc GSK- and Pfizer Inc PFE-owned company has received the approval of the United States Food and Drug Administration.

What Happened: The injectable — Cabenuva — is designed to replace the current treatment of HIV in adults which is based on taking daily pills.

Cabenuva is a Cabotegravir and Rilpivirine formulation. The treatment is meant for those patients who are on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to the two drugs.

The agency also approved Cabotegravir — sold under the brand name Vocabria, which should be taken in combination with Edurant (rilpivirine) for a month prior to starting treatment with the injectable.

“This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement. The injectible reduces the HIV treatment dosing days from 365 days to 12 days per year.

Why It Matters: Both Cabenuva and Vocabria — made by United Kingdom’s ViiV Healthcare, were granted fast track and priority review designation by the FDA.

The treatment costs involve $5,940 for a one-time initiation dose and $3,960 a month for the follow-up doses at wholesale price, according to Stat News. A ViiV spokesperson told the health publication that the initiation dose will be made available to the patients at no charge and described the costs involved with monthly doses to be well “within the range” of HIV treatment pills.

Last month, the company bagged the European Union’s marketing authorization for its HIV injections and tablets. 

See Also: HIV Diagnoses Are Falling

Rival Gilead Sciences GILD which also makes HIV drugs generated $17.2 billion in revenue from such treatments and grabbed 80% of the market share.

Cowen analyst Phil Nadeau expects HIV medication sales to bring in $24.4 billion in 2025.

Price Action: GSK shares closed nearly 0.6% lower at $37.38 on Thursday in New York. On the same day, Pfizer shares closed mostly unchanged at $36.48 and fell 0.16% in the after-hours session.

Editor's Note: An earlier version of this story wrongly implied that the entire treatment could be available at no charge to the patients. We regret the error.