After remedies to NDA, Intarcia’s diabetes implant under FDA review again

More than two years after well-funded Intarcia received a complete response letter from FDA, an NDA for the company’s implantable pump to treat Type II diabetes is back under the agency’s review.

The new PDUFA date for ITCA 650, which delivers exenatide through a matchstick-sized subcutaneous pump, is March 9, 2020. Intarcia Therapeutics Inc. said Tuesday that using its Medici delivery system, ITCA 650 would be implanted twice yearly to deliver the glucagon-like peptide-1 receptor (GLP-1R; GLP1R) agonist...