5.10

Editas sees clinical promise with new FDA pediatric disease tag for another blood disorder

Following a management shake-up, Editas Medicine received some welcome good news. The biotech has scored a second rare pediatric disease designation from the FDA for its gene edited medicine EDIT-301.

EDIT-301 already holds the designation for treating sickle cell disease and is currently under investigation in a clinical study. Following the FDA’s most recent designation, Editas expects to launch a phase 1/2 study of EDIT-301 in patients with transfusion-dependent beta thalassemia this year.

The gene editing biotech has been making headlines recently, but not necessarily for its clinical treatments. The company announced several leadership shake-ups, bringing on Sarepta’s Chief Medical Officer Gilmore O’Neill to replace Chairman, President and CEO James Mullen, who will become Editas’ executive chairman, effective June 1. Interestingly, O’Neill himself isn’t filling the biotech’s chief medical officer role, which currently sits empty after the company ousted Lisa Michaels, M.D., without explanation in February.

Click here to read the full article at Fierce Biotech

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

Add a Comment

Your email address will not be published. Required fields are marked *