Type:Notice
Citation:86 FR 9514
Reading Time:about a minute or two
The Food and Drug Administration (FDA) has awarded a priority review voucher to Alnylam Pharmaceuticals Inc. for their product, OXLUMO (lumasiran) injection. This product is used to treat a rare disease called primary hyperoxaluria type 1, which helps lower urinary oxalate levels in both children and adults. The voucher is part of a program set by the Federal Food, Drug, and Cosmetic Act, which recognizes drugs designed for rare pediatric diseases. The FDA is required to announce when such vouchers are awarded.
Simple Explanation
The FDA gave a special "golden ticket" to a company called Alnylam for making a medicine that helps kids with a very rare sickness. This golden ticket makes it faster for any of their future medicines to get approved more quickly.