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Gilead builds case for Xeljanz rival filgotinib as it preps US filing

Rheumatoid arthritis drug is already under review in Europe and Japan


Gilead Sciences has reported new, longer-term clinical data with its JAK inhibitor filgotinib in rheumatoid arthritis, already under review in Europe and Japan, as it gets ready to file in the US.

The 52-week results from the FINCH 1 and FINCH 3 trials in moderately-to-severely active RA are consistent with efficacy and safety data from 12- and 24-week readouts reported earlier this year, says Gilead, which licensed filgotinib from Belgian biotech Galapagos.

In particular, the two partners say filgotinib matched the safety profile seen at earlier timepoints, including thrombotic events that have been a cause for concern across the JAK inhibitor class.

The longer-term data will be needed as the two companies prepare for what is likely to be a tough battle as it fights for market share as the fourth JAK inhibitor to reach the market for RA after Pfizer’s Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s recently-approved Rinvoq (upadacitinib).

Filgotinib is an important new product for Gilead, which is trying to diversify its product portfolio, in the face of slumping sales of its hepatitis C drugs and greater competition in its HIV franchise, to include new areas like cancer, liver disease and immunology.

“We are encouraged by the durability of both the efficacy and safety profiles of filgotinib seen in these studies,” said John Sundy, Gilead’s head of inflammation and respiratory diseases.

“This data suggests that filgotinib, if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.”

Gilead and Galapagos filed for approval of filgotinib in Europe in August, and followed that with a submission in Japan last week. They expect to complete the US marketing application before the end of the year.

They hope to convince regulators and physicians that filgotinib has a better safety profile than its rivals, which will be key to making an impact in the increasingly crowded market.

The thrombosis side effect held up the approval of Lilly’s Olumiant by the FDA and eventually resulted in a green light for only a lower dose of the drug, which analysts have suggested will struggle to compete.

In July, Xeljanz – first to market and still the biggest product with sales of $1.8bn last year – had a ‘black box’ warning added to its label to draw attention to the risk of thrombosis at its higher 10mg twice-daily dose.

Meanwhile, Rinvoq was also approved with a black box warning that analysts have suggested means this will be applied across all JAK inhibitors, including filgotinib, and could limit the future sales potential of the class.

Article by
Phil Taylor

11th October 2019

From: Research



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