The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing for Xolair (omalizumab), marking it as the first treatment in the U.S. aimed at reducing allergic reactions associated with accidental food exposure in patients with food allergies. The FDA granted biologic breakthrough therapy designation (BTD) for this indication in 2018 and is expected to make a decision in the first quarter of 2024.
This submission is bolstered by interim results from a late-stage trial, which successfully met its primary and secondary endpoints, demonstrating a significant increase in the quantity of food required to trigger allergic reactions in patients aged 1 to 17 years. The study is co-sponsored by Roche and fellow Swiss firm Novartis (NYSE: NVS).
Xolair was initially approved in the U.S. in 2003 and is currently indicated for moderate-to-severe persistent allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP).- Flcube.com
