bluebird bio Announces Partial Clinical Hold for Patients Under 18 in Sickle Cell Gene Therapy Clinical Program

bluebird bio, Inc. announced on December 20th that the FDA has placed its clinical program for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease (SCD) on partial clinical hold for patients under the age of 18. The partial, temporary suspension relates to an ongoing investigation by bluebird bio into an adolescent patient with persistent, non-transfusion-dependent anemia following treatment with lovo-cel, now 18 months post-treatment. This patient is clinically well and there is no evidence of malignancy or clonal predominance. Enrollment and dosing for patients 18 and older living with SCD in the HGB-206, HGB-210 and LTF-307 clinical studies, as well as follow up for treated patients of all ages in all studies are continuing as planned.

For further information see Market Screener (https://www.marketscreener.com/quote/stock/BLUEBIRD-BIO-INC-13430435/news/bluebird-bio-Announces-Partial-Clinical-Hold-for-Patients-Under-18-in-Sickle-Cell-Gene-Therapy-Clini-37376162/?utm_content=20211220&utm_medium=RSS)

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