AbbVie $ABBV is one step closer to achieving its goal of rolling out a closely-watched drug for rheumatoid arthritis as the third late-stage study in the program delivered another round of promising results. But it’s still being dogged by safety issues that may yet come back to haunt the effort.
Researchers say that the JAK-1 inhibitor upadacitinib (better known as ABT-494) handily beat out methotrexate as a monotherapy among patients who weren’t adequately responding to the standard generic. The key figures:
A response of ACR20/50/70 was achieved by 68/42/23 percent of patients receiving 15 mg upadacitinib and 71/52/33 percent of patients receiving 30 mg of upadacitinib. That compares to 41/15/3 percent of patients continuing on methotrexate. Twenty-eight percent and 41% of patients in the 15 mg and 30 mg groups achieved clinical remission, respectively, compared to 8% of patients continuing on methotrexate.
AbbVie managed to startle investors recently with news of the death of two patients in one study. And this time it has to explain that another patient in the low-dose arm died of a hemorrhagic stroke caused by a ruptured aneurysm while there was also a case of pulmonary embolism in the same group. That followed a report in September that a patient taking a 30 mg dose experienced heart failure and presumed pulmonary embolism. In the most recent cases, both patients had already exhibited risks for these conditions, according to AbbVie.
But that didn’t shake its belief that they have a blockbuster drug on their hands, especially as it continues to roll out positive results. And it’s recently added positive data on atopic dermatitis as well. Company execs have pegged this drug as a top earner capable of bringing in $4 billion to $5 billion a year.
Rheumatoid arthritis is a big target for drug developers. It’s also a difficult one, as Eli Lilly found out when the FDA initially rejected baricitinib, demanding a new study. The FDA dropped that demand after Scott Gottlieb was named FDA commissioner.
The biggest recent approval came for Regeneron and Sanofi, which won an OK to market sarilumab after posting data demonstrating its ability to outperform Humira, AbbVie’s big drug.
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