Bluebird bio-gene therapy lovo-cel was once again clinically shelved by the U.S. FDA

Compilenewborn

Only half a year after the clinical shelving was lifted, Bluebird Bio-hematology gene therapy once again encountered clinical shelving by the US FDA

And just a month ago, Bluebird Bio had announced that it planned to submit a lovo-cel listing application to the FDA in the first quarter of 2023

Part of the shelving this time was because a teenage patient developed "persistent transfusion-free anemia" after receiving a one-time lovo-cel treatment

The latter sentence is very important because it was not until June this year that the FDA lifted the clinical trials of another gene therapy betibeglogene autotemcel (beti-cel) for the treatment of SCD and β-thalassemia

The latest partial clinical shelving marks another downturn in Bluebird's roller coaster journey this year

Despite the approval, Zynteglo and another newly approved gene therapy Skysona (elivaldogene autotemcel, Lenti-D) are no longer available in the EU, and the latter has been approved for the treatment of cerebral adrenoleukodystrophy (CALD)

In the United States, Zynteglo's application for the treatment of β-thalassemia and Skysona has won priority review by the FDA

In November last year, the FDA rejected the application of lovo-cel when the agency requested an "analytical comparability strategy" for the manufacturing process of the final commercial product relative to the clinical drug candidate

At the same time, in November, Bluebird Bio spun off its oncology project and established an independent listed company called 2seventy bio

Reference source: Bluebird bio hits FDA clinical hold—again—for gene therapy in sickle cell disease