Drugs

IntraBio Reports Positive Phase 3 Data on Levacetylleucine

IntraBio is reporting positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neurological symptoms in patients with ataxia-telangiectasia, a rare and progressive neurodegenerative disease with no approved treatments. The trial met its primary endpoint, the company says, demonstrating a statistically significant and clinically meaningful improvement on the Scale for the Assessment and Rating of Ataxia after 12 weeks of treatment compared with placebo.

Patients treated with levacetylleucine showed a 1.88-point improvement on the scale relative to placebo, with high statistical significance, IntraBio says. The trial also met key secondary endpoints, including improvements on the International Cooperative Ataxia Rating Scale and the Investigator’s Clinical Global Impression of Improvement. It says the drug was generally safe and well tolerated, with no drug-related serious adverse events reported, and a safety profile consistent with prior experience.

Based on the results, IntraBio says it plans to move forward with regulatory submissions in the U.S., Europe and other jurisdictions.

Ataxia-telangiectasia is described as a rare inherited disorder that typically begins in early childhood and leads to progressive loss of coordination, impaired speech and eye movements, immune system deficiencies, and a sharply increased cancer risk.

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