inspirator schreef op 18 juni 2017 18:22:
Hoe snel gaat koers Galapagos naar 100 euro ?
5 Answers to Questions Gilead Sciences' Investors Probably Have
Gilead Sciences executives provide some answers at the Goldman Sachs healthcare conference.
Keith Speights (TMFFishBiz) Jun 18, 2017 at 11:42AM
3. What are the prospects for filgotinib?
The FDA stunned Lilly (NYSE:LLY) and Incyte (NASDAQ:INCY) by not approving JAK inhibitor baricitinib for treating rheumatoid arthritis. What does Gilead make of the situation, since the biotech has its own JAK inhibitor, filgotinib, in phase 3 testing for rheumatoid arthritis as well as Crohn's disease and ulcerative colitis?
Bischofberger said that he has "no insights beyond what was published" regarding the FDA decision. However, he noted that Gilead first approached the FDA about conducting a study with only one dose, but the FDA pushed the company to use two doses. He now wonders if perhaps the FDA knew something about baricitinib then, since the agency requested more clinical data from Lilly and Incyte for determining the appropriate doses.
Filgotinib, which Gilead licensed from Galapagos (NASDAQ: GLPG), now has 1,700 patient-years of safety data, according to Bischofberger. It was the safety data that Galapagos presented from phase 2 studies that was really attractive to Gilead. He added that he feels "very confident that this compound will make it through" to the approval proces
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