Kweewel schreef op 25 september 2015 21:10:
Begrijp ik het goed dat Abbvie filgotinib niet vertrouwt vanwege mogelijke intoxicatie van de testikels? Of betekent testicular iets anders? Zie Barrons.com:
[AbbVie] was very surprised by the strength of the efficacy data in the TNF refractory population (they were “thrilled” when they saw it). This was a major factor in their decision to prioritize their internal JAK over Galapagos (we are examining this claim and will publish when we have completed our analysis).
The rat finding of testicular toxicity for the Galapagos molecule also impacted the company’s decision. The company believes this issue could take additional time to discuss with the FDA and thus could extend timelines. In addition, AbbVie believes the top dose of the Galapagos molecule best meets the company’s efficacy criteria, and that, given the testicular signal this could slow FDA discussions. We believe this issue is part of what underlies the “less uncertainty” phrase in the AbbVie press release today