Drug Development

J&J, GSK advance their PhIII IL-6 rheumatoid arthritis drug down to a busy red zone

A few months after spelling out the pivotal data behind a new rheumatoid arthritis drug that J&J believes is on track to becoming a blockbuster, the pharma giant and its collaborators at GlaxoSmithKline have submitted sirukumab for European approval, with an FDA application still in the works.

Paul-Peter Tak, GSK

Paul-Peter Tak, GSK

Back in June, investigators noted the 50 mg and 100 mg dose of sirukumab triggered a minimum 20% improvement in RA symptoms (ACR20) among 54.8% and 53.5% of patients in the two drug arms. The placebo arm experienced an ACR20 rate of about half that, 26.4%.

Those numbers will likely be at the heart of one of the most competitive new rivalries in its field. Sirukumab is an IL-6 drug, and there are a variety in development now that will challenge J&J and GSK in the coming scramble for market share. Ablynx recently posted Phase IIb ACR20 rates ranging from 62% to 81% in a variety of patient groups taking vobarilizumab.

AbbVie paid $175 million upfront to partner on vobarilizumab, but now has to decide if it will take it into Phase III. Last fall, AbbVie axed a collaboration it has in place with Galapagos for their JAK1 inhibitor filgotinib (GLP0634), saying it preferred to take their in-house program for ABT-494 into Phase III for arthritis. And Gilead immediately stepped into AbbVie’s big shoes, picking up filgotinib for a whopping $725 million up front and $1.3 billion in milestones.

Paul-Peter Tak, GSK’s Chief Immunology Officer & Senior Vice President R&D Pipeline, said:

“We have worked with our partner Janssen to develop a robust regulatory package to support the use of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis. We believe sirukumab, if approved, will provide these patients with a once every four week subcutaneous treatment option.”

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Sr. Manager, Regulatory Affairs, CMC
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