FDA tentatively approves generic lenacapavir for HIV prevention — STAT News

In the United States, the Food and Drug Administration (FDA) has tentatively approved Dr. Reddy’s Laboratories to manufacture a generic version of the injectable drug lenacapavir for HIV prevention. The decision is a step toward expanding access to the medicine in dozens of low- and middle-income countries.

Supplies are planned for next month

As STAT News reports, Dr. Reddy’s Laboratories, one of the world’s largest manufacturers of generic medicines, plans to begin supplying the drug next month. Several global health organizations are also involved in supplying the drug to lower-income countries.

The annual cost of the drug for one person will be $40. According to the publication, this is comparable to the cost of daily pills for HIV prevention.

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The injection is administered once every six months

Lenacapavir is an injectable drug administered once every six months. It is considered an important tool for overcoming HIV because, under this treatment regimen, it provides almost complete protection against infection with the virus.

The original drug is sold in the United States by Gilead Sciences under the name Yetzugo. The FDA approved the branded version of the drug last year.