FDA News

FDA approves Dexilant for patients aged 12 to 17 years with GERD

Takeda Pharmaceuticals announced the FDA has approved Dexilant for patients aged between 12 and 17 years with GERD. The medication has been approved for adults since 2009.

“Takeda is pleased with the FDA’s approval to expand the access of Dexilant [dexlansoprazole] to younger patients with GERD,” Thomas Gibbs, senior vice president of general medicines at Takeda, said in a press release. “This new approval provides an alternative treatment option for appropriate patients with this condition.”

Both dexlansoprzole delayed-release capsules and dexlansoprazole SoluTab delayed-release orally disintegrating tablets were approved, according to the release. Dexlansoprzole is a proton pump inhibitor that treats heartburn and erosive esophagitis associated with GERD, a chronic condition affecting 20% of the U.S. population. In patients with GERD, the lower esophageal sphincter does not close as tightly as it should or relaxes too often, which can cause stomach contents to move into the esophagus, leading to heartburn and erosive esophagitis.

For this new group of patients, the regular delayed release capsules are indicated in 30 mg and 60 mg formulations for the healing of all grades of erosive esophagitis up to 8 weeks, maintaining the healing of erosive esophagitis and relief of heartburn up to 16 weeks and treating heartburn associated with symptomatic non-erosive GERD for 4 weeks. In addition, the orally disintegrating capsules are indicated in a 30 mg formulation for the same thing, except for healing of all grades of erosive esophagitis up to 8 weeks.

“With more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions,” Gibbs said.

Takeda Pharmaceuticals announced the FDA has approved Dexilant for patients aged between 12 and 17 years with GERD. The medication has been approved for adults since 2009.

“Takeda is pleased with the FDA’s approval to expand the access of Dexilant [dexlansoprazole] to younger patients with GERD,” Thomas Gibbs, senior vice president of general medicines at Takeda, said in a press release. “This new approval provides an alternative treatment option for appropriate patients with this condition.”

Both dexlansoprzole delayed-release capsules and dexlansoprazole SoluTab delayed-release orally disintegrating tablets were approved, according to the release. Dexlansoprzole is a proton pump inhibitor that treats heartburn and erosive esophagitis associated with GERD, a chronic condition affecting 20% of the U.S. population. In patients with GERD, the lower esophageal sphincter does not close as tightly as it should or relaxes too often, which can cause stomach contents to move into the esophagus, leading to heartburn and erosive esophagitis.

For this new group of patients, the regular delayed release capsules are indicated in 30 mg and 60 mg formulations for the healing of all grades of erosive esophagitis up to 8 weeks, maintaining the healing of erosive esophagitis and relief of heartburn up to 16 weeks and treating heartburn associated with symptomatic non-erosive GERD for 4 weeks. In addition, the orally disintegrating capsules are indicated in a 30 mg formulation for the same thing, except for healing of all grades of erosive esophagitis up to 8 weeks.

“With more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions,” Gibbs said.