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Gilead's filgotinib combos fall short in lupus and Sjögren’s syndrome

Published on 28/10/19 at 01:01pm

Gilead’s impending regulatory submission of its JAK inhibitor filgotinib to the FDA for the treatment of rheumatoid arthritis has been marred by its failure in mid-stage trials elsewhere, the company has admitted.

Studies investigating the efficacy of combos built on the drug in the treatment of the immune system disorders cutaneous lupus and Sjögren’s syndrome failed to meet their primary endpoints, Gilead execs conceded in a results call.

The lupus trial investigated the performance of filgotinib in combination with the Syk kinase inhibitor lanraplenib, while the Sjögren’s syndrome evaluated the efficacy of these two drugs in addition to a BTK inhibitor known as tirabrutinib.

However, the company maintains there is still hope for the drug in these indications; two of the company’s partners are also pushing forward with an ongoing trial in membranous arthritis, a condition similar to lupus.

“We did see evidence of activity with filgotinib, particularly in patients who had markers or evidence of more active disease. So, we just got the first look at these data, we're looking at the full set of data from all of these studies and we'll determine the next steps that we take in lupus and Sjogren's disease,” explained Gilead Senior Vice President John Sundy.

Matt Fellows

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