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GSK’s Benlysta given orphan drug status by FDA for systemic sclerosis

February 1, 2023

Via: PMLiVE
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The antibody will now benefit from the incentives given to those drugs granted orphan status through the FDA’s ODD programme, introduced by the organisation to improve the availability of treatments for rare diseases.

Affecting two to ten people per million, SSc is a rare autoimmune disease that causes unusual growth of connective tissues and can affect a patient’s musculoskeletal system, heart, lungs, kidneys, skin and other organs.

Interstitial lung disease (ILD) is a common and serious complication of SSc, marked by inflammation and scar tissue build-up in the lungs, and is the leading cause of death in patients living with the disease.

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