Drugs

FDA Tells Catalyst it Needs More Firdapse Trials

FDA has told Catalyst Pharmaceuticals that it will need positive results from an additional study of the company’s Firdapse (amifampridine phosphate) in patients with Lambert-Eaton myasthenic syndrome (LEMS) before the agency will accept Catalyst’s NDA for filing. FDA told the company that it is open to discuss a study design that could efficiently accomplish the requirement with a small, short-term study. FDA also wants several additional short-term toxicology studies. The drug has been given breakthrough therapy and orphan drug designations for its proposed LEMS indication and is also seeking an indication for congenital myasthenic syndrome.

Catalyst officials say they are surprised by the request for an additional clinical study, and are in discussions with FDA on the protocol and logistics for the study. They say they are continuing Firdapse development for additional indications and have recently started a study in patients with MuSK-antibody positive myasthenia gravis. Catalyst also expects to complete this year a clinical trial of Firdapse in pediatric patients with congenital myasthenic syndrome.

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