FDA approves bluebird’s sickle cell disease gene therapy. Can Lyfgenia overcome CRISPR’s halo?

Fierce Pharma December 8, 2023
Angus Liu

Alongside an historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell disease (SCD).

The gene therapy, Lyfgenia (lovo-cel) from bluebird bio, is now approved to treat patients 12 years and older with SCD with a history of a type of painful episodes called vaso-occlusive events (VOEs). Lyfgenia comes with a list price of $3.1 million, bluebird said Friday.

The FDA announced the approvals of Lyfgenia and Vertex and CRISPR Therapeutics’ CRISPR-based Casgevy (exa-cel) together on Friday, firing the starting gun on a race between two different gene therapies. Vertex is pricing Casgevy lower at $2.2 million.

Previously, the drug cost watchdog, the Institute...

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