Drugs

Sickle Cell Drug Misses Phase 3 Endpoint: Pfizer

Pfizer says a Phase 3 study of its investigational sickle cell disease drug inclacumab failed to meet the primary endpoint. THRIVE-131 is evaluating inclacumab, a P-selectin inhibitor, in 241 patients aged 16 and older with sickle cell disease who experienced between two and 10 vaso-occlusive crises (VOCs) in the prior year. Participants received either intravenous inclacumab or a placebo every 12 weeks for 48 weeks, according to the company.

Pfizer says the data showed that the drug did not significantly reduce the rate of VOCs compared with placebo. Inclacumab was generally well tolerated, with the most common side effects including anemia, joint pain, back pain, headache, malaria, sickle cell anemia with crisis, and upper respiratory infections, it says.

The data appear to be another setback for the company’s sickle cell drug portfolio. Last September, Pfizer withdrew all lots of Oxbryta (voxelotor) based on the totality of clinical and real-world data, which suggested an imbalance in VOCs and fatal events at that time. After further evaluation, a Pfizer data assessment on Oxbryta has been completed and shared with FDA and EMA, according to the company. “Pfizer is committed to publishing a comprehensive analysis that includes additional Oxbryta data and analyses this year," it 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