Drugs

FDA Raises Sabizabulin ‘Uncertainties’

In advance of an 11/9 meeting of the FDA Pulmonary-Allergy Drugs Advisory Committee, FDA medical reviewers are raising several “uncertainties” about a Veru request for an emergency use authorization for its investigational prostate cancer drug VERU-111 (sabizabulin) as a treatment for hospitalized adults with moderate to severe Covid-19 who are at high risk for acute respiratory distress syndrome. The reviewers aired their concerns in a briefing document released before the meeting.

The paper says the reviewers acknowledge that the single study submitted by Veru met its prespecified primary endpoint of all-cause mortality at Day 60. They also noted that the study was quite small in size (204 patients) compared to other therapeutic programs for patients hospitalized with Covid-19.

The reviewers say the uncertainties with the trial data include:

high placebo group mortality rate;
potential for unblinding events with enteral tube administration;
baseline imbalances in standard-of-care therapies;
differences in hospitalization duration before trial enrollment;
uncertain effects of goals of care decisions on all-cause mortality;
negative studies with other microtubule disruptors in Covid-19; and
uncertainty in the identification of a clinically relevant patient population.

The agency is asking the advisory committee to:

discuss the all-cause mortality data and specifically address the extent to which the data could have been affected by the uncertainties raised by the reviewers;
discuss the level of concern with the limited size of the safety database for this new molecular entity; and
consider whether the known and potential benefits of VERU-111 when used to treat specific Covid-10 adult patients outweigh the known and potential risks.

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