Takeda receives additional FDA approval for GI drug; Cancer Research UK to test gemcitabine for advanced pancreatic cancer
→ The FDA has given the green light to Takeda to extended the indication of its drug Gattex (teduglutide) for injection to pediatric patients 1 year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).
→ More than a decade after the FDA first approved Fragmin to treat blood clots in adults, Pfizer has won an OK to extend its use in pediatric patients as young as one month old. There’d been no FDA-approved therapies to treat venous thromboembolism in this population, Richard Pazdur said in a statement, who are often suffering from a serious underlying condition such as cancer and congenital heart disease. The approval was based on a single trial with 38 patients, in which “21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE.”
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