FDA Grants Orphan Drug Status to GSK’s Systemic Sclerosis Therapeutic

February 3, 2023

The US Food and Drug Administration has granted Orphan Drug Designation (ODD) to GSK’s Benlysta (belimumab). The designation applies to the use of Benylsta in treating the interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a rare autoimmune connective tissue disorder. The drug is currently approved for treating active lupus and lupus nephritis.

According to Emily Kimber, “Research indicates that elevated levels of B-lymphocyte stimulator (BLyS) and autoreactive B cells play a central role in the development of SSc. A human monoclonal antibody, Benlysta inhibits the prolonged survival of B cells induced by increased BLyS, including autoreactive B cells. It is already approved in the US, the EU and Canada to treat active systemic lupus erythematosus (SLE) – the most common type of lupus – with its initial FDA approval in 2011 making it the first new drug approved to treat lupus in 56 years.”

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