(Sharecast News) – Pharmaceuticals giant GSK announced on Monday that its majority-owned HIV specialist subsidiary ViiV Healthcare has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for ‘cabotegravir’ long-acting (LA) injectable and tablets for HIV prevention.
The FTSE 100 company said that in Europe, significant progress had been made in the delivery of HIV treatment and prevention services, resulting in a continuous decline in the incidence of new HIV cases.
Nonetheless, around 100,000 new diagnoses are reported each year.
If approved, it said cabotegravir LA would offer a new prevention option for individuals at risk of HIV acquisition, administered as few as six times per year.
The firm said the positive opinion from the EMA was based on data from two international multicentre, randomised, double-blind, active controlled studies.
It said the studies evaluated the safety and efficacy of cabotegravir LA for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women at increased risk of acquiring HIV.
The results demonstrated that cabotegravir LA for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
In one of the studies, clinical trial participants receiving cabotegravir LA experienced a 69% lower rate of HIV acquisition compared to those taking FTC/TDF tablets, and in the other, participants on cabotegravir LA had a 90% lower rate of HIV acquisition compared to FTC/TDF tablets.
GSK sad cabotegravir LA for PrEP was already approved for use in the United States, Australia, Zimbabwe, South Africa, Malawi, Botswana, and Brazil under the name Apretude.
It said submissions to other regulatory agencies were currently underway.
“The expansion of prevention options is critical if we are to end the HIV epidemic,” said ViiV’s head of research and development, Kimberly Smith.
“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.”
Dr Smith said ViiV Healthcare was “at the forefront” of science, developing solutions to address the biggest unmet needs in HIV prevention.
“With the CHMP positive opinion, we are hopeful that people in Europe will soon be able to benefit from greater choice.”
Reporting by Josh White for Sharecast.com.