Drugs

NeuroSense Gets FDA Agreement for ALS Study

NeuroSense Therapeutics says it will begin a Phase 3 study by mid-2025 of PrimeC (ciprofloxacin and celecoxib) for treating amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease). The decision to proceed to a Phase 3 study is based on positive data from a Phase 2b study and feedback from FDA on the study’s design, including efficacy and safety measurements, according to the company.

Because PrimeC is an extended-release oral formulation of a unique fixed-dose combination of two FDA-approved drugs, the company says it will eventually seek approval under the 505(b)(2) NDA pathway. “PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation to potentially inhibit the progression of ALS,” it says.

The company notes that its recently completed Phase 2a clinical trial met its safety and efficacy endpoints, including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity.

NeuroSense plans to submit a final protocol to FDA early next year. It will enroll about 300 patients that will be divided by a 2:1 PrimeC to placebo ratio, the company says. Following 12 months of treatment, it is expected that all participants will transition to PrimeC for a 12-month open label extension.

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