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.
Immune Disorders
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Certain Immune Globulin Products Withdrawn Due to Higher Rate of Hypersensitivity Reactions
The IGIV and IGSC products were voluntarily withdrawn due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
Lilly Ends Baricitinib Lupus Program, Provides Update on Atopic Dermatitis sNDA
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
Novel Immunomodulator Gets Orphan Drug Status for Sarcoidosis
Results from a phase 1/2 showed that ATYR1923 was safe and well tolerated.
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.
Rethymic Approved for Pediatric Congenital Athymia
Rethymic is engineered human allogeneic thymus tissue designed to reconstitute the immune system in pediatric patients with congenital athymia.
Jakafi Approved for Chronic Graft-vs-Host Disease
The approval was based on data from the phase 3 REACH3 study which included 329 patients.
Ruzurgi Tablets Recalled Due to Yeast, Mold, Bacterial Contamination
The tablets may be contaminated with yeast, mold, and aerobic bacterial.
Abatacept Gets Priority Review for Moderate to Severe Acute Graft vs Host Disease
The supplemental Biologics License Application is supported by data from the phase 2 ABA2 trial (ClinicalTrials.gov Identifier: NCT01743131) and real world evidence from a registry trial.
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