Sedana Medical receives FDA fast track designation in the US

Sedana Medical AB today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the evaluation of isoflurane via the Sedaconda ACD-S device for sedation of mechanically ventilated patients in the intensive care (ICU) setting.

Fast Track is a process designed to facilitate the development, and expedite the review of therapies that treat serious conditions and fill an unmet medical need. The purpose is to get important new therapies to the patient earlier. Clinical programs with Fast Track Designation may benefit from frequent communication with the FDA throughout the development and review process and may be eligible to Accelerated Approval and Priority Review if relevant criteria are met. Another possible benefit may be a Rolling Review, which means that completed sections of the New Drug Application (NDA) can be submitted for review by FDA, rather than waiting until every section of the NDA is completed.

“The FDA’s decision to grant Fast Track Designation underscores the potential for our product candidates to address a serious unmet need and bring meaningful benefits to ventilated patients in intensive care. We are fully committed to work even more closely with FDA to bring our therapy to US patients as soon as possible,” said Johannes Doll, CEO of Sedana Medical. “This excellent news represents an important step forward in our highest potential market.”

Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and the pharmaceutical isoflurane for sedation of mechanically ventilated intensive care patients in the United States. Two identical Phase III studies, INSPiRE-ICU 1 and 2, are ongoing with the objective to confirm the efficacy and safety of inhaled sedation with isoflurane delivered via Sedaconda ACD in intensive care.

Sedana Medical will engage in discussions with the FDA on how the development program can benefit from the FTD. At present, the guidance regarding the timeline is unchanged: assuming rapid enrolment of patients and successful trials, Sedana Medical expects the NDA submission in 2024 and a launch in early 2025.
MB Bureau