First Injectable HIV Drug Get Approval By FDA

Mar, 2022 - by CMI

Newly injectable HIV drug Apretude approved by FDA can give to patients every two months, rather than a daily pill.

The agency announced on December 20,2021, that the FDA has approved the first long-lasting injectable drug Apretude to be used as an unveiling prevention against HIV. Daily intake of Truvada and Discovy (both are the existing pills to prevent HIV) has been shown to lower the risk of HIV by 99%. But the injectable drug Apretude which is an alternative to these pills, given every two months have shown same result. To analyse the safety and effectiveness of the Apretude, FDA conducted two different trials. Within these trials FDA found that it was more effective than daily pills to reduce HIV, it shown 90% efficacy in cisgender women and 69% efficacy in transgender women and cisgender men have sex with men. The best efficacy of the Apretude is clearly demonstrated by the fact that the study participants adhered to every-other-month diet as compared to taking one pill per day.

According to the CDCP, although PrEP use has been profitable through the past several years, only 25% of the 1.2 million people who were recommended for PrEP were prescribed treatment last year. The CDCP estimates that by 2019, there will be about 285,000 people using PrEP, with the majority of gay and bisexual men. Newly approved drug is manufactured by ViiV Healthcare and owned by GlaxoSmithKline, it is expected that will make compliance easier, help increase PrEP usage and bring down the national HIV rate.

In July 2021, the federal government disclosed that almost all insurance companies must include PrEP pills, two approved forms of Truvada and Descovy, as well as the clinic visits and lab tests required to maintain such a prescription, at no cost. That is, insurance companies are not required to cover all costs for the Apretude which has a least price of $ 3,700 per dose and will be available in the U.S. by early 2022. Will begin shipping to wholesalers and specialized distributors in. Meanwhile, several other long-acting forms of PrEP are making their way through the research pipeline, which rarely requires dosing twice a year.