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

 
• By Sue Sutter

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

The US Food and Drug Administration’s denial of a rare pediatric disease priority review voucher for bluebird bio’s sickle cell treatment Lyfgenia (lovotibeglogene autotemcel, or lovo-cel) could prompt calls for the agency to re-examine how it interprets the term “active ingredient” in the context of gene therapies.

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