Avapritinib Gets Priority Review for Indolent Systemic Mastocytosis
The sNDA is supported by data from the phase 2 PIONEER trial that evaluated the efficacy and safety of avapritinib in patients with indolent systemic mastocytosis.
The sNDA is supported by data from the phase 2 PIONEER trial that evaluated the efficacy and safety of avapritinib in patients with indolent systemic mastocytosis.
The new room temperature storage condition for Asceniv and Bivigam is immediately effective.
The approval was based on data from an expanded access program which evaluated the safety of amifampridine in 21 pediatric patients for at least 1 year.
Leniolisib is a small molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating and potentially antineoplastic activities.
The approval was based on data from the phase 3 ADVOCATE trial, which evaluated Tavneos in 330 adults with newly diagnosed or relapsed ANCA-associated vasculitis.
The approval was based on data from a phase 1/2 trial that included patients 1 year to less than 22 years of age with cGVHD after failure of 1 or more lines of systemic therapy.
Optic neuritis is a rare autoimmune disease characterized by the inflammation of the optic nerve.
In preclinical studies, efzofitimod was found to prevent inflammation and fibrosis in multiple animal models of systemic sclerosis and idiopathic pulmonary fibrosis.
The new expiration date for Asceniv and Bivigam is immediately effective and applies to all existing lots currently in the commercial supply chain and to future production.
The IGIV and IGSC products were voluntarily withdrawn due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.