Drugs

FDA Panel Votes Down Lipocine Testosterone Product

FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has voted 13 to six to not recommend approved for a Lipocine NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism).

This is the second NDA review for Tlando. Last year, the agency sent a complete response letter that identified deficiencies related to the dosing algorithm for the label, noting that the titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial, leading to discordance in titration decisions between the trial and real-world clinical practice.

In briefing materials, FDA reviewers said it appeared that Tlando had cardiovascular safety concerns because during clinical trials it appeared to raise heart rate and increase systolic blood pressure. Agency cardiologists recommended that Lipocine perform an ambulatory blood pressure monitoring study to further assess the effects of Tlando on blood pressure and heart rate.

During open testimony, Public Citizen Health Research Group’s Sidney Wolfe also questioned the therapy’s cardiovascular risk. “Combined with the unacceptable pharmacokinetics, other serious questions of its safety, and the availability of many other more predictable versions of testosterone, neither the advisory committee nor the FDA should consider its approval,” he said. Wolfe also shot down any consideration of requiring post-approval studies to address the safety issues: “The question FDA is asking you, whether such studies could be done after approval, is not acceptable in the context of a then-to-be-mass-marketed, but yet unproven drug.”

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