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Efzofitimod Granted Orphan Drug Status for Systemic Sclerosis > Immune Disorders

Category: Immune Disorders

Efzofitimod Granted Orphan Drug Status for Systemic Sclerosis
Dermatological Disorders General Immune Disorders Musculoskeletal Disorders News Respiratory Diseases/Disorders

Efzofitimod Granted Orphan Drug Status for Systemic Sclerosis

Steve Duffy April 13, 2022

The Food and Drug Administration (FDA) has granted Orphan Drug designation to efzofitimod (ATYR1923) for the treatment of systemic sclerosis. Efzofitimod is a potential first-in-class selective modulator of neuropilin-2 that is designed to downregulate innate…

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FDA Extends Shelf Life of Immune Globulin Products Asceniv and Bivigam
General Immune Disorders Miscellaneous Immune Disorders News

FDA Extends Shelf Life of Immune Globulin Products Asceniv and Bivigam

Steve Duffy March 30, 2022

The Food and Drug Administration (FDA) has approved an extended shelf life for both Asceniv (immune globulin intravenous [human] – slra) 10% Liquid and Bivigam® (immune globulin intravenous [human]) 10% Liquid from 24 to 36…

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Certain Immune Globulin Products Withdrawn Due to Higher Rate of Hypersensitivity Reactions
General Hematology Immune Disorders Infectious Disease Neurologic Disorders News

Certain Immune Globulin Products Withdrawn Due to Higher Rate of Hypersensitivity Reactions

Steve Duffy March 9, 2022

Several lots of immune globulin products have been voluntarily withdrawn as a precautionary measure due to reports of allergic/hypersensitivity type reactions, some of which were considered medically significant. The Immune Globulin Intravenous (IGIV) products mentioned…

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Lilly Ends Baricitinib Lupus Program, Provides Update on Atopic Dermatitis sNDA

Top-Meds January 28, 2022

Lilly has decided to discontinue the phase 3 development program for baricitinib in adults with active systemic lupus erythematosus. The decision was made based on data from 2 pivotal phase 3 trials, SLE-BRAVE-I (ClinicalTrials.gov Identifier:…

Novel Immunomodulator Gets Orphan Drug Status for Sarcoidosis

Top-Meds January 6, 2022

The Food and Drug Administration (FDA) has granted Orphan Drug designation to ATYR1923 for the treatment of sarcoidosis. Sarcoidosis is a rare inflammatory disease characterized by the formation of granulomas in the body, most commonly…

Rethymic Approved for Pediatric Congenital Athymia
General Immune Disorders Inborn Errors Of Metabolism Metabolic Disorders Miscellaneous Immune Disorders News

Rethymic Approved for Pediatric Congenital Athymia

MPR October 12, 2021

The Food and Drug Administration has approved the Biologics License Application for Rethymic® (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia. Rethymic is intended to…

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Tavneos Approved for ANCA-Associated Vasculitis
Autoimmune Disorders General Immune Disorders Miscellaneous Immune Disorders News

Tavneos Approved for ANCA-Associated Vasculitis

MPR October 8, 2021

The Food and Drug Administration has approved Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including…

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Jakafi Approved for Chronic Graft-vs-Host Disease
General Hematologic Disorders Immune Disorders News

Jakafi Approved for Chronic Graft-vs-Host Disease

MPR September 23, 2021

The Food and Drug Administration has approved Jakafi® (ruxolitinib) for the treatment of chronic graft-versus-host disease (GVHD) after failure of 1 or 2 lines of systemic therapy in patients 12 years of age and older.…

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Ruzurgi Tablets Recalled Due to Yeast, Mold, Bacterial Contamination
Autoimmune Disorders General Immune Disorders Miscellaneous Immune Disorders News

Ruzurgi Tablets Recalled Due to Yeast, Mold, Bacterial Contamination

MPR September 14, 2021

Jacobus Pharmaceutical Company is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10mg tablets due to yeast, mold, and aerobic bacterial contamination based laboratory test results. The 3 recalled lots of Ruzurgi 10mg tablets; NDC 49938-110-01,…

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Abatacept Gets Priority Review for Moderate to Severe Acute Graft vs Host Disease
General Hematologic Disorders Immune Disorders News

Abatacept Gets Priority Review for Moderate to Severe Acute Graft vs Host Disease

MPR June 23, 2021

The Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for abatacept (Orencia) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years…

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