Bluebird Bio to Sell Sickle Cell FDA Voucher for $103 Million if Therapy Approved

(Reuters) -Bluebird bio said on Monday it has agreed to sell its priority review voucher for $103 million if it gets the U.S. Food and Drug Administration’s approval for its gene therapy to treat sickle cell disease.

The voucher, which is transferable, allows a drug developer to expedite the review process of its product even if it does not fit requirements for a quick process.

This would be the third priority voucher sale for bluebird after selling two for a combined $197 million over the past one year.

The FDA’s decision is expected by Dec. 20 and the bluebird therapy could potentially be the second for the rare disease.

Sickle cell disease leads to a shortage of healthy blood cells and restricts blood circulation, causing periodic episodes of pain in patients.

The FDA’s advisers are scheduled to meet on Tuesday to decide on the sickle cell disease gene therapy jointly developed by Vertex Pharmaceuticals and Crispr Therapeutics. The regulator is expected to decide on the therapy by Dec. 8.

Both the therapies are one-time treatments, compared to the current regimen requiring frequent blood transfusions or once-daily drugs such as Pfizer’s Oxbryta.

(Reporting by Leroy Leo in Bengaluru; Editing by Shilpi Majumdar)

Copyright 2023 Thomson Reuters.