FDA Awards Amplia Orphan Drug Designation for Pancreatic Cancer

What's happened?

Amplia Therapeutics Limited (ASX: ATX, “Amplia”) today announced that the United States Food and Drug Administration (FDA) has awarded Amplia’s Focal Adhesion Kinase inhibitor (FAKi) AMP945 Orphan-Drug Designation for the treatment of pancreatic cancer.

What are the key highlights?

1. The designation means that Amplia will qualify for waived FDA fees, clinical trial protocol assistance and other incentives.
2. If the FDA ultimately approves AMP945 for the treatment of pancreatic cancer, Amplia would qualify for seven years’ market exclusivity in FDA-administered markets.
3. Amplia is aiming to start a Phase 1 clinical trial of AMP945 in healthy volunteers later this year to confirm that, like other FAKi, it is well tolerated.