Drugs

FDA OKs Gilead’s Descovy for HIV Prevention

FDA has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for use in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. The drug was first approved in 2016 in combination with other antiretoviral drugs to treat HIV-1 infection in adults and pediatric patients.

An FDA release says PrEP is an HIV prevention method in which people who do not have HIV take medicine on a daily basis to reduce their risk of getting HIV if they are exposed to it. “Descovy for PrEP should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections,” it says.

Approval was based on data from a double-blind multinational trial in 5,387 HIV-negative men and transgender women who have sex with men and were at risk of HIV-1 infection. The trial compared once daily Descovy to Gilead’s other PrEP therapy Truvada (emtricitabine, tenofovir disoproxil fumarate, 200 mg/300 mg). The primary endpoint was the rate of HIV-1 infection in each group, and data showed that Descovy was similar to Truvada in reducing the risk of acquiring HIV-1 infection. The most common adverse reaction was diarrhea.

The approval also required a boxed warning for those who take Descovy who also have hepatitis B virus (HBV) to be aware of the risk of exacerbations of HBV if they discontinue Descovy therapy.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome