Drugs

ViiV Healthcare 2-drug HIV Regimen Approved

FDA has approved a ViiV Healthcare NDA for Dovato (dolutegravir and lamivudine), as a complete regimen for treating human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato. The agency says this is the first two-drug, fixed-dose, complete regimen for HIV-infected adults. The current standard of care for patients who have never been treated is a three-drug regimen.

Approval was based on data from two identical, randomized, double-blind, controlled clinical trials in 1,433 HIV-infected adults with no prior antiretroviral treatment history. “The trials showed that a drug regimen containing dolutegravir and lamivudine had a similar effect of reducing the amount of HIV in the blood compared to another drug regimen, which included dolutegravir, emtricitabine, and tenofovir,” FDA says. “The treatment was considered successful if the patient maintained low-levels (less than 50 copies/mL) of HIV RNA in their blood for at least 48 weeks.”

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