Bluebird’s Zynteglo Launch Under Way, But First Revenue Will Take Months

First Sales Of Newly Approved Product Expected In Q1 2023

Bluebird bio will not see revenue for Zynteglo until it is infused into beta-thalassemia patients, which will take months due to the ex vivo gene therapy’s complex manufacturing and quality control process.

Genetic engineering concept. Medical science. Scientific Laboratory.
Manufacturing and quality control will take 70-90 days for each Zynteglo dose • Source: Shutterstock

The launch of bluebird bio’s newly approved gene therapy Zynteglo (betibeglogene autotemcel) in the US is under way, but the firm does not expect to recognize any revenue from its first commercial product until the first quarter of 2023. Bluebird will not record sales until the treatment is infused into beta-thalassemia patients, and because of the ex vivo gene therapy’s manufacturing process and quality control requirements, it will be next year by the time Zynteglo is administered commercially.

The US Food and Drug Administration approved Zynteglo for the treatment of children and adults with beta-thalassemia who require regular...

More from New Products

More from Scrip

Jazz Seeks Potential Expansion Of Epilepsy Franchise With Saniona Deal

 
• By 

Deal Snapshot: Jazz, which sells Epidiolex for rare seizure disorders, will pay $42.5m up front to take over development of Saniona’s preclinical Kv7.2/Kv7.3 activator SAN2355 for epilepsy.

Madrigal Regains Lead With Rezdiffra MASH Approval In EU

 
• By 

Four days after Wegovy became the second approved MASH therapy in the US, Rezdiffra gets the first European approval. Plans are for an initial launch in Germany.

Celldex Bullish On Barzolvolimab Despite Study Miss

 
• By 

All eyes on chronic urticaria after eosinophilic esophagitis disappointment.