Watch out AbbVie: Gilead is fast on your heels at the FDA with rival JAK inhibitor filgotinib
Moving fast with what it believes is a blockbuster favorite in a crowded market, Gilead has confidently plotted an NDA filing for filgotinib by the end of the year, setting up a potential 2020 launch in rheumatoid arthritis.
Smooth progress here would minimize AbbVie’s lead, as its rival JAK inhibitor upadacitinib is already under priority review with a PDUFA date set for Q3. For analysts, it’s also a testament to new CEO Dan O’Day’s ability to execute on key pipeline advances, having hinted at the quick filing in an investor call — though questions about a crucial safety study remain unanswered.
SVB Leerink anaylsts call the scenario “better than our best case” as it sets up a potential launch six months ahead of their projected timeline. Gilead’s partners at Galapagos $GLPG enjoyed a 6% rally at the news.
Gilead solidified its intent to file after a recent meeting with the FDA, in which the company updated regulators about the Phase III FINCH studies as well as the ongoing Phase II safety study dubbed MANTA. Analysts have described that trial — which evaluates the toxicity of filgotinib in men with moderately to severely active ulcerative colitis or Crohn’s disease — as a “key overhang” for the drug.
With the entire JAK class grappling with safety issues — the FDA and EMA both issued stark warnings recently about the dangers posed by Pfizer’s Xeljanz, and Eli Lilly was denied an approval on the high dose of Olumiant — a clean score on this front is required to stand out.
“Filgotinib’s impressive safety profile could be an important differentiator, potentially key to driving uptake despite likely being the 4th JAKi to market,” Jefferies’ Peter Welford noted, referring to the lower rates of cardiovascular events compared to placebo.
There’s no word on when MANTA will read out, but the assumption is that regulators have agreed to judge the application on interim data rather than waiting on the full dataset, expected in 2020.
As for efficacy, analysts are in general agreement that filgotinib appears similar to upadacitinib, AbbVie’s next-gen answer to the $20 billion Humira franchise.
FINCH 1 and FINCH 3 saw ACR20/50/70 results that overshadowed the sugar pill response levels as well as a methotrexate arm. While the low 100 mg data were generally in line with Humira, the 200 mg outperformed the aging blockbuster, set to lose patent protection no later than 2023.
In case anyone needs a reminder, the stakes are high. Welford sees $6 billion in filgotinib in terms of worldwide sales potential across all indications, with $3 billion from rheumatoid arthritis, $600 in Crohn’s, $400 million in ulcerative colitis and $2 billion from others. Evan Seigerman from Credit Suisse, meanwhile, forecasts a more conservative $1 billion in peak RA sales while other indications should bring in $1 to $2 billion.
Social image: Kristoffer Tripplaar, AP Images