FDA grants priority review to Linzess for functional constipation in children, teens
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The FDA has granted priority review to a supplemental new drug application for Linzess for the treatment of functional constipation in patients aged 6 to17 years old, according to an Ironwood Pharmaceuticals press release.
The company noted that the FDA has assigned the Linzess (linaclotide 72 mcg, AbbVie/Ironwood) application a Prescription Drug User Fee Act date of June 14, 2023 — approximately 4 months earlier than the standard review cycle.
“Pediatric functional constipation has a significant impact on young patients and their families, yet there are no FDA-approved prescription therapies available for this population,” Michael Shetzline, MD, PhD, chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals, said in the release. “We welcome the FDA’s decision to grant priority review, as it brings us even closer to potentially changing the treatment landscape for pediatric patients aged 6 to 17 years-old with this condition.”
The filing for the application was based on results from a multicenter, double-blind, phase 3 study, which evaluated Linzess in 330 patients aged 6 to17 years old with functional constipation. Patients were randomly assigned 1:1 to either Linzess or placebo.
Results of this study demonstrated that Linzess met the primary endpoint vs. placebo, with a statistically significant and clinically meaningful improvement from baseline in 12-week spontaneous bowel movement (SBMs/week) frequency rate. Patients treated with Linzess vs. placebo showed a greater than two-fold squares mean change form baseline in SBMs/week (P<0.0001). Additionally, there were statistically significant improvements with Linzess vs. placebo with regards to the change from baseline to week 12 in stool consistency, evaluated with the Bristol Stool Form Scale.
Linzess was well-tolerated in this pediatric population, results showed, with diarrhea reported to be the most common adverse event.
“As a company focused on advancing the treatment of [gastroenterology] diseases, we have worked with a sense of urgency to expand the clinical utility of linaclotide to this underserved pediatric population with functional constipation,” Tom McCourt, CEO of Ironwood Pharmaceuticals, said. “If approved, we look forward to a commercial launch mid-2023.”
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