By Carl O’Donnell
(Reuters) – Global Blood Therapeutics Inc said on Monday it plans to ask U.S. regulators to greenlight the use of its sickle cell treatment, Oxbryta, in children between ages 4 and 11, expanding on an earlier approval for patients 12 and over.
The South San Francisco, California-based company recently met with the U.S. Food and Drug Administration and plans to submit a formal application for an expanded approval next year, it said in a statement. The company is continuing to collect data supporting Oxbryta’s safety and effectiveness in children between 4 and 11 but existing data is strong, Chief Executive Ted Love told Reuters in an interview.
(Reporting by Carl O’Donnell; Editing by Leslie Adler)
