FDA Approves New PrEP Drug Ahead of Truvada Going Generic

FDA Approves New PrEP Drug Ahead of Truvada Going Generic

CYBERSPACE  — The U.S. Food and Drug Administration this week approved Descovy as a second PrEP drug for at-risk adults, except for those who have receptive vaginal sex. The announcement arrives ahead of PrEP drug Truvada going generic next year.

“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” said Jeffrey Murray, M.D., M.P.H., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”

Earlier this year, POZ Magazine reported on research that concluded Descovy “is an effective and safer option for PrEP” for gay and bi men and trans women” and “may be a better PrEP alternative for people at risk for kidney problems.”

A generic version of current PreP drug Truvada will be available September 2020; only one company, Teva Pharmaceutical Industries, is allowed to sell it. Gilead Sciences manufactures both Truvada and Descovy.

"The approval of generic versions of meds is usually met with praise because it means significant cost savings to the consumer — and therefore more access to people who need the medicine. But the case of generic Truvada seems to raise more questions than acclaim," wrote POZ earlier this summer.

It’s unclear if access to generic PrEP will result in cost savings and improved access to necessary medication versus "mass exodus to high-cost Descovy," said Tim Horn, the director of medication access and pricing at the National Alliance of State & Territorial Directors.

“Historically,” he told POZ, “when there’s only one generic manufacturer in the field, the price difference is a miniscule 10 percent to 15 percent. The real savings for all purchasers and payers won’t begin until there’s robust generic competition.”

For related information, including healthcare concerns, visit the Free Speech Coalition's Inspire program for adult industry members; learn more about PrEP here.

Image source: POZ Magazine; Gilead Sciences

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