FDA News

FDA extends Gattex indication to 1 year and up with short bowel

The United States FDA has approved an extension of the indication for Gattex to include injection in pediatric patients with short bowel syndrome aged 1 year and older who need additional nutrition fluids through intravenous feeding, according to company press release.

Gattex (teduglutide, Takeda) mimics glucagon-like peptide-2, which helps patients absorb more nutrients, a critical goal of treating short bowel syndrome.

“Addressing high unmet needs of patients with complex and debilitating gastrointestinal conditions is a focus of Takeda’s work,” Andrew Grimm, global clinical development lead at Takeda said in the press release. “As the first U.S.-approved therapy in pediatric SBS patients dependent on [parenteral support (PS)] that improves absorption, Gattex offers these patients new hope to reduce PS requirements and the potential for PS independence. This approval underscores Takeda’s commitment to patients with rare and devastating GI conditions like SBS.”

Researchers explored the efficacy of Gattex in a 24-week study comprising patients aged 1 year to 17 years. They found that 69% of patients who receive 0.05 mg/kg per day were able to reduce PS volume by at least 20%, and 38% were able to reduce PS infusion by at least 1 day per week. Three patients who received that dosage of Gattex were able to wean off PS completely, according to the press release.

Disclosures: Grimm is employed by Takeda.

 

The United States FDA has approved an extension of the indication for Gattex to include injection in pediatric patients with short bowel syndrome aged 1 year and older who need additional nutrition fluids through intravenous feeding, according to company press release.

Gattex (teduglutide, Takeda) mimics glucagon-like peptide-2, which helps patients absorb more nutrients, a critical goal of treating short bowel syndrome.

“Addressing high unmet needs of patients with complex and debilitating gastrointestinal conditions is a focus of Takeda’s work,” Andrew Grimm, global clinical development lead at Takeda said in the press release. “As the first U.S.-approved therapy in pediatric SBS patients dependent on [parenteral support (PS)] that improves absorption, Gattex offers these patients new hope to reduce PS requirements and the potential for PS independence. This approval underscores Takeda’s commitment to patients with rare and devastating GI conditions like SBS.”

Researchers explored the efficacy of Gattex in a 24-week study comprising patients aged 1 year to 17 years. They found that 69% of patients who receive 0.05 mg/kg per day were able to reduce PS volume by at least 20%, and 38% were able to reduce PS infusion by at least 1 day per week. Three patients who received that dosage of Gattex were able to wean off PS completely, according to the press release.

Disclosures: Grimm is employed by Takeda.