Abbvie has not managed to avoid a black box warning with its supposedly safer Jak inhibitor, upadacitinib – which could be a bad omen for Galapagos and Gilead’s rival project, filgotinib. Upadacitinib, now brand named Rinvoq, bagged US approval on Friday for rheumatoid arthritis, but the label warning for thrombosis – similar to that seen with the older Jak inhibitors Xeljanz and Olumiant – is bad news for Abbvie as the company looks for fresh sales as Humira biosimilars take hold. Rinvoq’s NPV of $10.6bn makes it the group’s fourth most valuable product, but this forecast could now come down. The development looks like worse news for Galapagos and Gilead: analysts now expect all the Jak inhibitors to carry similar warnings, and this would be a blow to the companies’ claims that filgotinib could be the safest Jak in an autoimmune setting. If filgotinib cannot be differentiated on safety Galapagos and Gilead, which has US marketing rights, could struggle against Abbvie’s marketing machine. Hitting Jak 2 has been blamed for an increased thrombosis risk, but this theory remains unproven, and the FDA’s prudent stance could spur doctors to err on the side of caution with the whole class.
|Bleeding risk: Jak inhibitors in autoimmune diseases|
|Product||Company||Mechanism||Status||2024e sales ($bn)||12-month change in 2024 forecast|
|Xeljanz||Pfizer||Jak 1, 2 & 3 inhibitor||Approved for RA, psoriatic arthritis, ulcerative colitis||3.4||+8%|
|Rinvoq (upadacitinib)||Abbvie||Jak 1 inhibitor||Approved for RA||2.5||+15%|
|Filgotinib||Galapagos/Gilead||Jak 1 inhibitor||Filed in EU, US filing planned by YE 2019||1.3||-18%|
|Olumiant||Lilly||Jak 1 & 2 inhibitor||Approved for RA||1.1||-16%|