The Food and Drug Administration (FDA) may approve the first long-acting therapy for HIV pre-exposure prophylaxis (PrEP) within the next few months.On Tuesday, the pharmaceutical company ViiV Healthcare announced that the FDA has accepted and granted priority review for a new drug application (NDA) for cabotegravir, an injectable form of PrEP administered every two months.
The FDA’s target approval date is Jan. 24, 2022.Created in 2009 by Pfizer and GlaxoSmithKline, ViiV Healthcare specializes in HIV treatment and prevention.The NDA was based on the results of two double-blind studies that evaluated the safety and efficacy of cabotegravir.
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