News
FDA, Alpha-1 Foundation and Office of Public Health plan workshop on measuring efficacy of alpha-1 augmentation
The Food and Drug Administration (FDA) is announcing a public workshop entitled: “Improving Endpoints, Improving Care: Alpha-1 Antitrypsin Augmentation Therapy and Clinical Trials.”
The workshop March 23-24 in Bethesda, MD, is intended to identify the most useful clinical trial endpoints and surrogate markers for alpha-1 antitrypsin (AAT) augmentation therapy.
The FDA, Alpha-1 Foundation and the Department of Health and Human Services, Office of Public Health and Science are convening the workshop to facilitate the design of future clinical trials intended to establish clinical efficacy of AAT products. The workshop will feature presentations and panel discussions led by experts from academic institutions, government and industry.
The public workshop will facilitate scientific discussions to identify the most relevant and feasible, currently available and future clinical trial efficacy endpoints for AAT augmentation therapy and further evaluate its usefulness to a broader patient population.
