GSK abandons regulatory submissions of rheumatoid arthritis drug

Drugmaker GSK revealed on Thursday that it will not proceed with regulatory submissions of its experimental treatment for moderate-to-severe rheumatoid arthritis after the drug candidate failed to meet a key endpoint in a recent study.

GSK said that a late-stage study on otilimab, its antibody-based drug, showed it failed to make a meaningful difference in improving swelling and tenderness in joints to aid movement in patients who had not previously responded to other forms of treatment.

"The limited efficacy demonstrated does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA," said GSK.

The FTSE 100-listed group also said it has come closer to locking in its first new drug approval since its consumer health spin-off back in July, with an expert panel of the Food and Drug Administration backing the approval for daprodustat - its drug aimed at treating anemia in certain patients with chronic kidney disease.

GSK's senior vice president of development Chris Corsico said: "Today's robust discussion was an important step in the review of daprodustat. We are pleased the committee recognised the potential for daprodustat to help certain patients who are living with anaemia of CKD given limited treatment options.

"We want to thank the physicians, patients, and advocacy community who shared their valuable insights about this disease. We look forward to continuing to work with the US FDA as they complete their review of our new drug application."

As of 0830 BST, GSK shares were down 0.30% at 1,390.80p.

Reporting by Iain Gilbert at Sharecast.com