Drugs

Restrictions Sought on Zelnorm sNDA

Hyman, Phelps & McNamara is asking FDA not to approve any sNDA to allow Zelnorm (tegaserod maleate) to be marketed unless the sNDA contains substantial evidence of safety and effectiveness for the proposed use in the proposed population under current applicable standards. In the alternative, an 11/21 petition says, if FDA approves a pending sNDA based on the evidence in it, the agency should include post-marketing obligations for the sponsor to conduct new clinical trials in accordance with the standards identified in current FDA guidance, the product labeling should be revised and updated to include, among other things, appropriate statements alerting prescribers that effectiveness has not been demonstrated to current standards in the indicated population, and the sponsor implement a communication REMS to ensure that the drug’s benefits outweigh its risks by making prescribers aware of the important limitations on its use and differences in the new approval compared to the old approval and compared to current standards.

The petition notes that Zelnorm was first approved by FDA 7/2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was approved 8/2004 for treating patients less than 65 years old with chronic idiopathic constipation.

In 2005, FDA identified a potential increased risk of suicidal ideation and behavior events and ordered the drug off the market in 2007. In 5/2012, the agency issued a Guidance, Irritable Bowel Syndrome—Clinical Evaluation of Drugs for Treatment setting forth the history and evolution of clinically relevant endpoints in IBS clinical trials and making recommendations for IBS clinical trial design and appropriate endpoints.

A 2/26/18 sNDA submitted by Sloan Pharma proposed to reintroduce Zelnorm for treating adult women under 65 years old with irritable bowel syndrome and a primary symptom of constipation who are at a low cardiovascular 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