Pharma Focus Asia

US FDA Granted Orphan Drug Designation for Benlysta

Thursday, February 02, 2023

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’s ODD granted will support the development and evaluation of potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders affecting fewer than 200,000 people in the US.

Systemic sclerosis (SSc) is a rare autoimmune disease that causes atypical growth of connective tissues which affects the musculoskeletal system, heart, lungs, kidneys, skin, and other organs. Interstitial lung disease (ILD) is the leading cause of death in SSc, affecting as many as half of people living with the disease.

magazine-slider-imageCytiva - Supor Prime filtersMFA + MMA 20244th Annual Cleaning Validation 20242nd Annual Pharma Impurity Conclave 2024CPHI Korea 2024CHEMICAL INDONESIA 2024World Orphan Drug Congress Europe 2024INALAB 2024Thermo Fisher - Drug Discovery and the impact of mAbsAdvanced Therapies USA 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference