Organovo receives FDA grant for 3D bioprinted tissue

H&E stained native human liver tissue exhibiting APAP toxicity (left); ExVive™ 3D Bioprinted Human Liver Tissue treated with increasing doses of APAP (right) Image: Organovo -

Organovo Holdings, Inc. (“Organovo”) has announced that the U. S. Food and Drug Administration (“FDA”) granted orphan drug designation for the Company’s treatment of alpha-1 antitrypsin deficiency (“A1AT”) with its 3D bioprinted liver therapeutic tissue.

The FDA Orphan Drug designation program provides incentives to sponsors that are developing therapies for rare diseases which affect fewer than 200,000 people in the United States. Organovo is now qualified to receive significant benefits throughout its orphan drug development program including more frequent FDA interactions, protocol assistance, and tax credits for clinical research costs. The designation also includes a waiver of certain fees and a seven-year term of market exclusivity upon FDA approval of the orphan drug, and can provide for a more streamlined and cost-effective path through to commercialization.