The Food and Drug Administration has approved Dexilant (dexlansoprazole) for gastroesophageal reflux disease patients aged 12-17 years, according to a press release from Takeda Pharmaceuticals.
FDA approval of Dexilant for this age group is based on adequate and well controlled studies proving its efficacy in adults, as well data on safety, pharmacokinetics, and efficacy in children 12-17 years. Dexilant is approved for younger patients to maintain healing of erosive esophagus and heartburn relief for 16 weeks, healing all grades of EE for 8 weeks, and treating heartburn associated with GERD for 4 weeks.
Dexilant is a proton pump inhibitor, prescribed to relieve heartburn associated with GERD and maintain healed erosive esophagus. The most common side effects seen in individuals aged 12-17 were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.
“Takeda is pleased with the FDA’s approval to expand the access of Dexilant to younger patients with GERD. This new approval provides an alternative treatment option for appropriate patients with this condition. With our more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions,” noted Thomas Gibbs, senior vice president of general medicine at Takeda.
Find the full press release on the Takeda Pharmaceuticals website .