Drugs

Linzess Approved for Pediatric Constipation

FDA has approved an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) to treat functional constipation in pediatric patients aged six to 17 years. Linzess is the first treatment for this condition and the recommended dosage is 72 mcg orally once daily, according to an agency release. Commonly experienced by children and adolescents, FDA says functional constipation is characterized by infrequent bowel movements with hard stools that can be difficult or painful to pass.

Approval is based on data from a 12-week placebo-controlled clinical trial (Trial 7; NCT04026113) and supported by efficacy data from adequate and well-controlled trials in adults with chronic idiopathic constipation, the release says. The primary efficacy endpoint was a 12-week change from baseline in spontaneous bowel movement (SBM) frequency rate. “Patients who received Linzess experienced a greater improvement in the average number of SBMs per week than patients who received placebo,” FDA says.

On the safety side, The most common adverse reaction reported was diarrhea. “If severe diarrhea occurs, patients should stop receiving Linzess and be rehydrated,” FDA says.

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