With its megamerger with Allergan in the books, AbbVie is focusing its growth on a stable of homegrown meds, including recent rheumatoid arthritis launch Rinvoq. Signs were looking good already—and an FDA rejection for Gilead Sciences' likely blockbuster rival could give AbbVie's med an even bigger leg up.
The FDA dropped a complete response letter on Gilead's JAK med filgotinib earlier this week, and it's likely to push that med's debut into 2022 at the earliest. That means Rinvoq has plenty of runway pad its lead in RA, Piper analysts said in a note to clients Wednesday.
The agency requested more data from two ongoing clinical trials, MANTA and MANTA-RAy, that are assessing the effect of the 200-mg dose of JAK1 inhibitor filgotinib on sperm concentrations in rheumatoid arthritis patients. Both studies are fully enrolled, Gilead said, and expect top-line results in the first half of 2021.
The delay could give Rinvoq time to not only hone its edge in RA but potentially add to its haul in other indications, too, including atopic dermatitis, or eczema.
"With Rinvoq already off to a robust start in RA, we think this development has to make (AbbVie's) commercial efforts that much easier," Piper analysts wrote.
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Of course, filgotinib's flop represents more than one win for AbbVie: Besides the fact that analysts expected Gilead's drug to snare $3 billion per year in RA alone, AbbVie had bailed on a $1.4 billion filgotinib deal with Galapagos in 2015 to focus instead on Rinvoq.
After AbbVie walked away, Gilead swooped in with its own $2 billion deal with Galapagos to develop filgotinib. Gilead upped the ante last year with a $5.1 billion expansion of its Galapagos partnership to access a broad swath of the biotech's pipeline.
Rinvoq sales have just been gearing up—$149 million in the second quarter—but AbbVie believes its most recently rheumatology launch is on its way to blockbusterland. Paired with another superstar launch, psoriasis med Skyrizi, the duo could skyrocket to a combined $20 billion in annual sales if AbbVie's dreams come true.
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