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.
Diagnosis & Disease Information
FDA Approves Room Temp Storage Conditions for Asceniv and Bivigam
The new room temperature storage condition for Asceniv and Bivigam is immediately effective.
Firdapse Approval Expanded to Children With Lambert-Eaton Myasthenic Syndrome
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 Gets Priority Review for Activated Phosphoinositide 3-Kinase Delta Syndrome
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.
Tavneos Approved for ANCA-Associated Vasculitis
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.
Imbruvica Approved for Pediatric Patients With Chronic Graft-vs-Host Disease
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.
Deoxycytidine Kinase Inhibitor Designated Orphan Drug for Optic Neuritis
Optic neuritis is a rare autoimmune disease characterized by the inflammation of the optic nerve.
Efzofitimod Granted Orphan Drug Status for Systemic Sclerosis
In preclinical studies, efzofitimod was found to prevent inflammation and fibrosis in multiple animal models of systemic sclerosis and idiopathic pulmonary fibrosis.
FDA Extends Shelf Life of Immune Globulin Products Asceniv and Bivigam
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.
Certain Immune Globulin Products Withdrawn Due to Higher Rate of Hypersensitivity Reactions
The IGIV and IGSC products were voluntarily withdrawn due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
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