Drugs

2-drug Combination Approved for Treating HIV-1

FDA has approved a ViiV Healthcare NDA for Juluca, the first complete treatment regimen containing two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1). Current HIV combination products include three or more drugs included in standard HIV treatment. “Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” CDER Division of Antiviral Products director Debra Birnkrant is quoted in a release as saying.

Approval is based on data from two clinical trials involving 1,024 patients whose virus was suppressed on their current anti-HIV drugs. Patients were randomly assigned to continue their current anti-HIV drugs or switch to Juluca. Data showed that Juluca was effective in maintaining virus suppression levels and results were comparable to those who continued their current therapy, the agency says.

During the trials, common side effects in patients taking Juluca were diarrhea and headache. However, serious side effects such as skin rash and allergic reactions, liver problems and depression or mood changes were also noted in some patients, FDA says.

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