Lovotibeglogene autotemcel is under clinical development by bluebird bio and currently in Phase III for Sickle Cell Disease. According to GlobalData, Phase III drugs for Sickle Cell Disease have a 47% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Lovotibeglogene autotemcel’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Lovotibeglogene autotemcel overview

Lovotibeglogene autotemcel (Lyfgenia) is a βA-T87Q-globin gene therapy acts as as a hematological agent. It is formulated as suspension for intravenous route of administration. Lyfgenia is indicated for the treatment of patients 12 years of age or older with sickle cell disease and a history of vaso-occlusive events. 

Lovotibeglogene autotemcel (bb1111) is under development for the treatment of sickle cell disease (SCD). It is administered through intravenous route as suspension. The therapeutic candidate comprises autologous CD34 positive hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene.

Bluebird bio overview

bluebird bio is a biotechnology company that focuses on the development and commercialization of gene therapies for the treatment of severe genetic diseases and cancer. The company develops its products based on integrated product platforms such as lentiviral gene addition platform, cancer immunotherapy and gene editing. Its product pipeline includes elivaldogene autotemcel for the treatment of cerebral adrenoleukodystrophy (CALD); betibeglogene autotemcel for transfusion-dependent beta thalassemia; Lovo-cel for the treatment of sickle cell disease, besides compounds under development for the treatment of various cancers. The company has collaboration with pharmaceutical companies to discover, develop and commercialize gene therapy products. bluebird bio is headquartered in Cambridge, Massachusetts, the US.

For a complete picture of Lovotibeglogene autotemcel’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.