2023-05-30 09:33:22 ET
- Inhibrx, Inc. ( NASDAQ: INBX ) announced Tuesday that the FDA granted Fast Track designation for its experimental therapy INBRX-101 as a treatment for patients with emphysema due to alpha-1 antitrypsin deficiency (AATD).
- Characterized by damaged air sacs in the lungs, emphysema leads to breathlessness, and most patients with the disorder also have chronic bronchitis.
- The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
- If certain criteria are met, such programs will also be able to win Accelerated Approval and Priority Review, enabling patients to access those treatments sooner.
- Inhibrx ( INBX ) is advancing INBRX-101 in a pivotal trial, with initial data expected in late 2024.
For further details see:
Inhibrx wins FDA fast track tag for lung disease candidate