FDA Approves Truvada For PrEP With Bolstered Labeling But No Restricted Distribution
This article was originally published in The Pink Sheet Daily
Concerned about impeding drug access for HIV treatment, the agency declined to restrict prescribing of Gilead’s antiretroviral for pre-exposure prophylaxis to documented evidence of a negative HIV test, although the label’s newly revised boxed warning highlights the need for confirmation of HIV-negative status.
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Descovy demonstrated noninferiority to Truvada in men and transgender women who have sex with men, but pharmacokinetic data do not support a demonstration of pre-exposure prophylaxis efficacy in cisgender women, US FDA says in advisory committee briefing document.
FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.