Drugs

Trulance NDA Approved for Expanded Indication

FDA has approved a Synergy Pharmaceuticals NDA for Trulance (plecanatide) 3 mg tablet for the once-daily treatment of irritable bowel syndrome with constipation (IBS-C) in adults. The drug was previously approved for treating adults with chronic idiopathic constipation (CIC).

Approval was based on data from the company’s Phase 3 IBS-C program that included two randomized, 12-week, double-blind, placebo-controlled trials. In both, Trulance met the primary endpoint as compared with placebo, according to the company, adding that patients who received the drug “experienced significantly reduced abdominal pain and improvements in stool frequency, stool consistency, and straining with bowel movements during the 12-week treatment period as compared to placebo.”

On the safety side, the most common adverse event in the studies was diarrhea, with severe diarrhea reported in 1% of patients, Synergy says. Overall discontinuation rates were low among patients treated with Trulance and placebo (2.5% vs. 0.4% at placebo) and the most common adverse reaction leading to discontinuation was diarrhea (1.2% vs. 0% in placebo).

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

Read more

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