Drugs

Ironwood Needs Another Apraglutide Trial: FDA

Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for its investigational drug apraglutide, following recent discussions with FDA on the drug’s approval path for treating short bowel syndrome with intestinal failure (SBS-IF). FDA is requiring a confirmatory trial after raising concerns with the earlier Phase 3 STARS trial data, the company says, adding that a pharmacokinetic analysis revealed the delivered dose was lower than intended, which prompted the agency action.

Ironwood says Apraglutide is a long-acting, once-weekly synthetic GLP-2 analog aimed at treating rare gastrointestinal conditions, including SBS-IF, which is described as a severe, chronic disorder that impairs nutrient absorption and often necessitates intravenous nutrition support.

In the STARS trial, apraglutide demonstrated a statistically significant reduction in weekly parenteral support volume, according to the company. Long-term extension data showed that 27 patients achieved enteral autonomy, meaning they no longer required intravenous nutrition, a major milestone for those living with SBS-IF, it says.

Ironwood intends to collaborate with FDA on the new trial’s design while continuing to monitor patients in the long-term extension study.

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