The following is from Medpage.
The first long-acting injectable for HIV prevention has now been approved for use, the FDA announced on Monday.
Long-acting injectable cabotegravir (CAB-LA, branded as Apretude) is administered as a monthly injection for the first 2 months, then every 2 months afterwards. It is the first long-acting injectable for pre-exposure prophylaxis (PrEP). The drug is approved for adults and adolescents weighing at least 77 lb.
This is the first option for HIV PrEP that does not involve taking a daily pill, noted FDA's Director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research, Debra Birnkrant, MD.
She added that this will help "high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option."
AVAC: Global Advocacy for HIV Prevention also applauded the news.
"With as few as six shots per year, this highly effective form of injectable PrEP can help bend the curve of the HIV epidemic – but only if its approval is accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the people who need prevention most," said AVAC Executive Director, Mitchell Warren, in a statement.
Of the 1.2 million individuals in the U.S. who are recommended for PrEP, only 25% are actually prescribed it, according to the FDA...
...CAB-LA's approval was based on two randomized trials, one in [men, including men who identify as women] and one in [women]. (Continued...)