Category: ODD/BTA/FTA Status Region: North America · United States Company: Glaxosmithkline Inc

Us Fda Granted Orphan Drug Designation For Benlysta

Us Fda Granted Orphan Drug Designation For Benlysta
Gsk Announced That The Us Food And Drug Administration (Fda) Has Granted Orphan Drug Designation (Odd) To Benlysta (Belimumab), A B-Cell Inhibiting Monoclonal Antibody, For The Potential Treatment Of Systemic Sclerosis. Gsk Plans To Initiate A Phase Ii/Iii Trial Of Belimumab For Systemic Sclerosis Associated Interstitial Lung Disease (Ssc-Ild) In The First Half Of 2023.With Limited Treatment Options Available For Ssc-Ild, The Orphan Drug Designation Reflects The Need For Further Research And The Potential For Belimumab To Address A Critical Need For People Living With This Debilitating Condition.The Us Fda

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