Apimeds and Lundefinedkahi Confirm FDA Meeting to Discuss LT-100
Apimeds Pharmaceuticals and Lundefinedkahi Therapeutics announced that the FDA Division of Anesthesiology, Addiction Medicine and Pain Medicine, or DAAP, has confirmed a Type C meeting to discuss LT-100 - Apitox -, a non-opioid biologic candidate being developed for the treatment of the signs and symptoms of osteoarthritis, or OA. The meeting will be conducted via teleconference on Monday, May 4. The scheduled interaction follows the recent submission of a Type C meeting request and represents an important step in the coordinated U.S. regulatory strategy for LT-100. The meeting is intended to support alignment with the FDA on key development considerations and the overall path forward for the program in the U.S. The product was originally developed and approved in South Korea, where it was approved for marketing in South Korea by the Korean Food and Drug Administration. Apimeds and Lundefinedkahi Therapeutics are now advancing the program in the U.S. by integrating its historical data with development standards.
