US FDA advisory panel votes against GSK kidney drug use in some cases

(Alliance News) - GSK PLC on Thursday said a US Food & Drug Administration panel has supported ...

Alliance News 27 October, 2022 | 9:02AM
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(Alliance News) - GSK PLC on Thursday said a US Food & Drug Administration panel has supported daprodustat for adults on dialysis but not for non-dialysis adults, and provided an update on the ContRAst phase III programme for otilimab.

The Brentford, London-based biopharmaceutical firm said the Cardiovascular & Renal Drugs Advisory Committee backed that the benefit of treatment with daprodustat outweighs the risks for adult dialysis patients with anaemia of chronic kidney disease with a 13 to 3 vote.

Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor.

However, in adult non-dialysis patients with anaemia of CKD, the CRDAC did not support that the benefit of treatment with daprodustat outweighs the risks, by a 5 to 11 vote.

CKD is an increasing global health burden affecting 700 million patients worldwide, GSK noted.

GSK Senior Vice President Chris Corsicosaid: "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."

Separately, GSK provided an update on the ContRAst phase III programme for otilimab, which is an investigational monoclonal antibody targeting granulocyte-macrophage colony-stimulating factor in the treatment of moderate to severe rheumatoid arthritis.

The firm said data from ContRAst-3, the third trial in the programme, did not support suitable benefit or risk profile for otilimab as treatment, when compared to placebo at week 12 in patients.

The ContRAst phase III programme was designed to compare the efficacy and safety of two doses of otilimab with placebo.

RA is a chronic, systemic inflammatory condition characterised by pain, joint swelling, stiffness, joint destruction and disability. It is estimated to affect 24.5 million people globally.

GSK said it expects full results from the ContRAst phase III programme will be submitted for publication in 2023.

Last Friday, GSK said a new drug application for its respiratory syncytial virus vaccine candidate has been accepted for review by the Japanese Ministry of Health, Labour & Welfare.

Share were flat at 1,395.20 pence each on Thursday morning in London.

By Xindi Wei; xindiwei@alliancenews.com

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GSK PLC 1,799.50 GBX 1.07

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