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GSK: Benlysta designated orphan drug by FDA

( - Alongside its quarterly results, GSK announced on Wednesday that the US FDA has granted orphan drug designation to Benlysta for the treatment of systemic sclerosis.

Benlysta, a monoclonal antibody that inhibits B-cell activation, is scheduled to enter a Phase II/III clinical trial for the treatment of systemic sclerosis in the first half of 2023.

This is a systemic connective tissue disease characterised by microvascular involvement and can affect the heart, lungs, kidneys and skin.

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