Drugs

FDA Approves Gilead’s Sunlenca for Some HIV Patients

FDA has approved Gilead’s Sunlenca (lenacapavir), described as a new type of antiretroviral medication for adult patients with human immunodeficiency virus type 1 (HIV-1) whose infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. An agency announcement says that after the oral tablet and subcutaneous injection starting dose arecompleted, Sunlenca is administered as subcutaneous injections once every six months.

The drug is the first in a new class called capsid inhibitors to be approved by the agency to treat HIV-1, the notice says. It works by blocking the HIV-1 virus’ protein shell, thus interfering with multiple essential steps of the viral lifecycle. It is given in combination with other antiretrovirals.

The efficacy and safety of Sunlenca were established through a multicenter clinical trial with 72 patients whose HIV infections were resistant to multiple classes of HIV medications, FDA says. The most common adverse effects were injection site reactions and nausea.

FDA granted Sunlenca priority review, fast track, and breakthrough therapy designations.

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