Bluebird’s Lost Voucher: Lyfgenia Contains Same ‘Active Ingredient’ As Zynteglo, US FDA Says

Surprise denial of rare pediatric disease priority review voucher could prompt calls for the agency to re-examine how it interprets the term ‘active ingredient’ for gene therapies. Bluebird asserts there are significant differences between its gene therapies for treating sickle cell and beta-thalassemia.

Reflection in water
When the FDA looked at Lyfgenia, it saw the same active ingredient as was in Zynteglo. • Source: Shutterstock

More from Cell & Gene Therapies

More from Advanced Technologies