FDA grants Orphan Drug Designation to belimumab for systemic sclerosis
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The FDA has granted Orphan Drug Designation to belimumab, a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis, according to a press release from GlaxoSmithKline.
The company added that it plans to initiate a phase 2/3 trial of belimumab (Benlysta, GlaxoSmithKline) for SSc-associated interstitial lung disease in the first half of 2023.
“With limited treatment options available for SSc-ILD, this 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,” read the release, in part. “GSK continues to follow the science to explore how belimumab may be able to address an unmet need in B cell-driven autoimmune diseases.”
The FDA’s Orphan Drug Designation is a status granted to support the development and study of new interventions in the treatment, diagnosis or prevention of rare diseases that impact fewer than 200,000 people in the United States.
In April 2022, the FDA granted Orphan Drug Designation to GS-248 (Gesynta Pharma), an oral small molecule, selective membrane-associated prostaglandin E synthase-1 (mPGES-1) inhibitor, for the treatment of SSc.
Belimumab is currently the only biologic approved by the FDA for both systemic lupus erythematosus and lupus nephritis, in adult and pediatric populations.
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