MANTA Brings Glimmer Of Good News To Galapagos
Promising Early Filgotinib Data Boosts Stock
After a difficult spell for the Belgian biotech, positive interim data from two key studies looking at testicular toxicity concerns over filgotinib suggest a pathway for potential future US approval of the Gilead-partnered JAK inhibitor for IBD.
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The Belgian biotech is pleased with the launch of its rheumatoid arthritis drug in Germany and the Netherlands and it has also secured a broad label from NICE.
The Galapagos and Gilead partnership has had a tough few months and the failure of ziritaxestat, plus the decision not to develop filgotinib Stateside for rheumatoid arthritis, is calling into question the merits of the whole collaboration for the US biotech.
A disappointing meeting with the FDA means "we no longer see a viable path to US approval in this indication,” said Gilead CEO Daniel O'Day, as Galapagos assumes sole responsibility for the commercialization of the JAK inhibitor in Europe.