Galapagos Knocked By Knee Osteoarthritis Fail
Servier-Partnered Drug Shows No Activity in Phase II
Still reeling from the FDA rejection of its JAK inhibitor filgotinib for rheumatoid arthritis, the Belgium-headquartered biotech's ADAMTS-5 inhibitor developed with France's Servier is sunk after failing to significantly reduce cartilage loss compared with placebo in an OA trial.
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Following a trio of high-profile setbacks, the Belgian biotech is looking to fill the gap between the European launches of its rheumatoid arthritis drug Jyseleca and its programs back in Phase II via in-licensing and M&A.
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.
The Belgian biotech has divested its drug discovery services unit in Croatia which was making a nice profit but was not a priority as Galapagos concentrates on setting up its commercial operations in Europe.