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Lupus Drug Is Approved Despite Previous Clinical Trial Setback

Lupus Drug Is Approved Despite Previous Clinical Trial Setback News & Analysis News From the Food and Drug Administration New Treatment Approved for Adults larial drug hydroxychloroquine, all of which tis while taking the drug. Other reported ad- and Children With Pompe Disease are standard treatments for SLE, can cause verse events included nasopharyngitis and A second enzyme replacement treatment organ damage and other adverse events. upper respiratory tract infection. has received approval for the treatment of Monoclonal antibodies like anifrolumab- late-onset Pompe disease in patients aged fnia can cause adverse events, too, but they “Collaborative Communities” Tackle 1 year or older. also may reduce the need for corticoste- Device Development Challenges People with late-onset Pompe disease roids. Anifrolumab-fnia improves symp- The FDA’s Center for Devices and Radiologi- cal Health is participating in a growing num- have genetic variants that create a defi- toms by inhibiting type I interferon signal- ciency of acid α-glucosidase (GAA), an en- ing, which is increased in people with SLE ber of public-private partnerships called “collaborative communities” that focus on zyme that helps break down glycogen into and is associated with more severe disease. glucose for energy. Without adequate GAA, Its predecessor, belimumab, blocks B lym- overcoming device development hurdles. Established by outside http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Lupus Drug Is Approved Despite Previous Clinical Trial Setback

JAMA , Volume 326 (11) – Sep 21, 2021

Lupus Drug Is Approved Despite Previous Clinical Trial Setback

Abstract

News & Analysis News From the Food and Drug Administration New Treatment Approved for Adults larial drug hydroxychloroquine, all of which tis while taking the drug. Other reported ad- and Children With Pompe Disease are standard treatments for SLE, can cause verse events included nasopharyngitis and A second enzyme replacement treatment organ damage and other adverse events. upper respiratory tract infection. has received approval for the treatment of Monoclonal antibodies like...
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Publisher
American Medical Association
Copyright
Copyright 2021 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2021.14964
Publisher site
See Article on Publisher Site

Abstract

News & Analysis News From the Food and Drug Administration New Treatment Approved for Adults larial drug hydroxychloroquine, all of which tis while taking the drug. Other reported ad- and Children With Pompe Disease are standard treatments for SLE, can cause verse events included nasopharyngitis and A second enzyme replacement treatment organ damage and other adverse events. upper respiratory tract infection. has received approval for the treatment of Monoclonal antibodies like anifrolumab- late-onset Pompe disease in patients aged fnia can cause adverse events, too, but they “Collaborative Communities” Tackle 1 year or older. also may reduce the need for corticoste- Device Development Challenges People with late-onset Pompe disease roids. Anifrolumab-fnia improves symp- The FDA’s Center for Devices and Radiologi- cal Health is participating in a growing num- have genetic variants that create a defi- toms by inhibiting type I interferon signal- ciency of acid α-glucosidase (GAA), an en- ing, which is increased in people with SLE ber of public-private partnerships called “collaborative communities” that focus on zyme that helps break down glycogen into and is associated with more severe disease. glucose for energy. Without adequate GAA, Its predecessor, belimumab, blocks B lym- overcoming device development hurdles. Established by outside

Journal

JAMAAmerican Medical Association

Published: Sep 21, 2021

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