- Gilead said Tuesday it plans to submit its experimental arthritis treatment filgotinib for U.S. approval this year, a speedier-than-expected timeline that could shorten the lead held by rival AbbVie for a competing drug.
- Filgotinib, one of a class of drugs known as JAK inhibitors, proved effective in treating rheumatoid arthritis in two Phase 3 studies that read out results earlier this year. A slow-enrolling male toxicity study required by the Food and Drug Administration, however, had looked set to delay an application from Gilead for filgotinib's approval.
- Now, after discussions with the FDA, Gilead intends to submit the drug this year, having established "a path forward" with the regulator. The change in plans is important, as analysts consider filgotinib to be Gilead's most important pipeline product.
A filing this year for filgotinib could set up a potential market launch in 2020, which would be one to two years earlier than some on Wall Street had been anticipating.
As AbbVie expects to win approval for its rival JAK inhibitor upadacitinib later this year, a sped-up timeline for Gilead could limit the time on market AbbVie has without a key rival.
Filgotinb and upadacitinib work similarly, and both are forecast to earn their respective makers billions of dollars in sales over time.
As it stands, AbbVie's drug would be the third JAK inhibitor for rheumatoid arthritis to reach market, and Gilead's the fourth. Both have posted strong efficacy in reducing the condition's characteristic joint swelling and tenderness.
AbbVie's application to the FDA was accepted by the agency in February under priority review, setting up a decision sometime in the third quarter.
Until Tuesday's announcement, Gilead's filing plans were somewhat uncertain due to the status of a Phase 2 testicular toxicity study known as MANTA. Previously, the biotech had indicated the trial was required for filgotinib's submission, making slow enrollment a concern among Wall Street analysts.
It's not clear whether the FDA will still want to see data from MANTA before making a decision on approval, but Tuesday's statement indicates at least that the study is no longer a limiting factor to an application.
"The FDA’s guidance by no means guarantees the acceptance of an NDA application or approval, but an earlier-than-expected submission improves filgotinib’s competitive positioning," wrote SVB Leerink analyst Pasha Sarraf in a note to clients.
One further wrinkle could be whether Gilead decides to use a priority review voucher for filgotinib. Such so-called regulatory fast passes accelerate the FDA's review timeline from the standard 10 months to six.
According to Cantor Fitzgerald analyst Alethia Young, Gilead has held onto one of the valuable PRVs and could use it to further speed filgotinib along. The drugmaker has previously used other PRVs on applications for approval of two HIV drugs and for a label expansion for Descovy (emtricitabine/tenofovir alafenamide).
Approval of filgotinib would be a key milestone for Gilead under its new CEO Daniel O'Day. Tuesday's announcement could help assure investors that the company stays on track.