Glaxo files US regulatory submission for sirukumab
GlaxoSmithKline has filed a regulatory submission to the US Food and Drug Administration for the use of sirukumab for the treatment of rheumatoid arthritis.
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More specifically, it is for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have failed or are intolerant to one or more disease-modifying antirheumatic drugs.
Sirukumab is being co-developed for RA as part of a collaboration with Janssen Biologics.
A regulatory submission to the European Medicines Agency was announced earlier in September. Sirukumab is currently not approved as a treatment for any indication anywhere in the world.
Paul-Peter Tak, GSK's chief immunology officer & senior vice president of the R&D pipeline, said: "We are pleased with the progress being made to seek regulatory approval of sirukumab in adult patients who, despite the use of conventional and biologic therapies, still suffer from moderately to severely active rheumatoid arthritis.
“If approved, sirukumab would provide these patients with another treatment option. This US submission follows one made for Europe earlier this month and we look forward to the outcome of the regulatory authority reviews."
At 1410 BST, GSK shares were up 0.1% to 1,651p.