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  • FDA says injectable PrEP a ‘breakthrough’ therapy as it pends approval
  • November 19, 2020

FDA says injectable PrEP a ‘breakthrough’ therapy as it pends approval

A needle/syringe
(Photo: Shutterstock)

The U.S. Food and Drug Administration (FDA) has designated injectable PrEP as a ‘breakthrough therapy’, according to the drug’s manufacturer.

Designating a treatment as a ‘breakthrough’ means the FDA has been impressed by trial results and will work with a pharmaceutical company to speed up a therapy going through the approval process. It doesn’t mean it’s granted approval just yet.

The announcement comes from ViiV Healthcare, which is majority-owned by GlaxoSmithKline. It’s developed an injectable PrEP treatment called cabotegravir. In recent trials, it compared the injectable PrEP to taking a daily dose of PrEP in tablet form. The injectable PrEP is administered once every eight weeks.

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Related: Long-acting PrEP injections show some benefits over daily tablets

One recent study, published in July, found the injectable PrEP to be 66% more effective at reducing HIV transmission. That study specifically looked at 4,500 transgender women and cisgender gay men who had sex with men.

When taken as directed, daily PrEP medication is highly effective at preventing someone from acquiring HIV. The only issue is that some people can occasionally forget to take their medication, meaning their resistance to HIV will drop.

ViiV said in a press statement, “The Breakthrough Therapy Designation means closer and more frequent collaboration with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support its approval.”

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Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “New medicines that decrease the risk of HIV acquisition in at-risk populations are an essential tool to help us end the global HIV epidemic.

“We are looking forward to working closely with the FDA to make this prevention option available to people at risk of acquiring HIV.”

According to the CDC, there were approximately 38,000 new HIV infections in the United States in 2018. This figure has fallen since the 1980s and 1990s but has remained around the same level since 2014. Gay and bisexual men make up around two-thirds of that figure each year.

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In 2019, President Trump pledged to eliminate HIV transmission in the US by 2030. President-Elect Joe Biden said during his campaign for the Presidency that he would strive to end “the HIV/AIDS epidemic by 2025,” and that this would include greater access to PrEP.

Related: 5 ways to get PrEP delivered to your doorstep

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