Drugs

Synergy Wants Linzess Labeling Changed

Synergy Pharmaceuticals is petitioning FDA to require changes to the approved package insert for Forest Laboratories’ Linzess (linaclotide) to ensure that it contains adequate information for its use because it “misrepresents or obfuscates the incidence of adverse events in its clinical trials in several respects.” The petition says a Forest NDA was approved by FDA 8/30/12 for using Linzess to treat irritable bowel syndrome with constipation and to treat chronic idiopathic constipation (CIC).

Synergy, which markets the rival product Trulance (plecanatide), cites these issues with the adverse event information in the Linzess package insert: the Adverse Reaction label section for CIC patients does not present adverse event information for the 72 mcg dose in tabular form to permit a rapid side-by-side comparison of adverse event rates; the labeling omits data for the 290 mcg dosage strength in CIC patients completely and doctors should be able to review those data because that strength is commercially available; the labeling does not disclose that clinical trial subjects could discontinue treatment for up to three days before resuming dosing, a practice that Synergy says could strongly affect the reported rate of discontinuations due to adverse reactions; and the labeling does not reveal that each event at a minimum must have met a threshold of being an “annoyance” to the patient for investigators to categorize the event as an adverse event.

“These omisions in the Linzess PI fail to provide healthcare professionals with the most important and relevant information they need in making treatment decisions and monitoring and advising patients,” the petition concludes.

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