Cabotegravir LA injectable and tablets are intended for usage as a pre-exposure prophylaxis to cut down HIV-1 infection risk. Credit: PENpics Studio / Shutterstock.com.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion recommending marketing authorisation to ViiV Healthcare’s cabotegravir for human immunodeficiency virus (HIV) prevention.

Cabotegravir long-acting (LA) injectable and tablets are intended for usage as a pre-exposure prophylaxis (PrEP) to cut down HIV-1 infection risk in adults and adolescents.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The latest development is based on findings from two global Phase IIb/III clinical trials which analysed the efficacy and safety of cabotegravir LA for PrEP. 

According to the HPTN 083 and HPTN 084 study findings, cabotegravir LA for PrEP demonstrated to be superior to oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) administered daily.

Furthermore, trial subjects who received cabotegravir LA had a 69% and 90% reduced HIV acquisition rate versus FTC/TDF tablets in HPTN 083 and HPTN 084 trials, respectively.

See Also:

In the US, Zimbabwe, South Africa, Australia, Botswana, Malawi and Brazil, cabotegravir LA for PrEP has received approval under the brand name Apretude.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

ViiV Healthcare research and development head Kimberly Smith said: “The expansion of prevention options is critical if we are to end the HIV epidemic.

“Long-acting options have the potential to play an important role in reducing challenges such as inconsistent adherence to taking daily pills, and stigma associated with oral PrEP use that can be faced by people who could benefit from PrEP.”

In June 2021, the company signed a collaboration and licence agreement with Halozyme Therapeutics to develop ‘ultra long-acting’ HIV drugs.