1. Scrip
  2. >>Advanced Therapies
  3. >>Gene Therapies

Bluebird’s Fast Lyfgenia Launch Was A Year And A Half In The Making

Zynteglo Build Gives Firm A Leg Up In Sickle Cell Disease

 
• By Mandy Jackson

The company said when Zynteglo was approved for beta-thalassemia that its launch would lay the groundwork for its sickle cell gene therapy Lyfgenia, and the strategy is paying off so far with a fast ramp-up.

DNA helix 3D illustration. Mutations under microscope. Decoding genome.
Bluebird's sickle cell gene therapy Lyfgenia launched in January • Source: Shutterstock

Bluebird bio inc.’s sickle cell disease gene therapy Lyfgenia (lovotibeglogene autotemcel) won US Food and Drug Administration approval on the same day in December as Vertex Pharmaceuticals Incorporated/CRISPR Therapeutics AG’s competing gene-editing medicine Casgevy (exagamglogene autotemcel), but as of the J.P. Morgan Healthcare Conference a month later bluebird’s product is in the lead in terms of qualified treatment centers (QTCs) ready to administer the drug and the number of patient lives covered by payers that have agreed to reimburse Lyfgenia’s multimillion-dollar cost.

Key Takeaways

  • Bluebird’s Lyfgenia launch to date has resulted in 35 qualified treatment centers ready to administer the sickle cell gene therapy in the US versus nine centers ready to administer Vertex/CRISPR’s gene-editing medicine.

The company said when it won FDA approval for its beta-thalassemia gene therapy Zynteglo (betibeglogene autotemcel) in August 2022 that...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Gene Therapies

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys.

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Rocket Comes Back To Earth With Restructuring Plan

 
• By Alaric DeArment

The biotech will lay off nearly one-third of its workforce and focus on its cardiovascular gene therapy programs.

The Duchenne Gene Therapies Lining Up To Take Elevidys’ Place

 
• By Andrew McConaghie

Regenxbio and Solid Biosciences believe they have a next-generation approach to AAV-based gene therapies – but must distance themselves from Sarepta’s safety and efficacy problems.

More from Conferences

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Scrip and Pink Sheet journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.

BIO Deal Trends: Financial Market Stress Creates Transactional Opportunities

 
• By Mandy Jackson

M&A may not be booming in 2025, but BIO convention attendees reported no shortage of potential deals, especially as cash-strapped drug developers seek funding alternatives.

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By Xu Hu

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.