Jyseleca European Launches Could Lift Gloom At Galapagos
Assuming Sole Responsibility From Gilead
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.
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The Belgian biotech's president, Bart Filius, tells Scrip that exiting the metabolic disease and osteoarthritis space and focusing on inflammation makes sense to "bring a bit more balance in terms of risk into our portfolio."
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.
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.