Gilead to File NDA for Filgotinib for Rheumatoid Arthritis
Meeting with the U.S. Food and Drug Administration (FDA) Gilead (GILD) announced it discussed with the agency the Phase 3 FINCH studies; as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with its filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result of this discussion a path forward has been established to submit the NDA for the approval of filgotinib to treat rheumatoid arthritis in 2019.
So, what is this all about?
At the Annual European Congress of Rheumatology (EULAR 2019), which took place on June 12-15, 2019, Gilead Sciences and Galapagos NV (GLPG) presented 24 week results from the ongoing FINCH 1 and FINCH 3 Phase 3 studies; evaluating filgotinib in adults with rheumatoid arthritis. The data presented were good enough to reinforce the firms’ belief that filgotinib has the potential to make a meaningful difference in patients with rheumatoid arthritis, when other treatments have failed.
The FINCH 3 Study
FINCH 3 is a randomized, double-blind, active-controlled Phase 3 study of the investigational, oral, selective JAK1 inhibitor filgotinib, in adults with moderately-to-severely active rheumatoid arthritis. The week 24 results of filgotinibin, in combination with methotrexate and as monotherapy in methotrexate (MTX)-naïve patients, demonstrate that the product in monotherapy, and in combination with MTX, achieved the primary endpoint at Week 24. The number was significantly higher for filgotinib 200 mg plus MTX and filgotinib 100 mg plus MTX compared with MTX alone.
The proportion of patients achieving clinical remission at Week 24 was also significantly higher in patients receiving once-daily filgotinib 100 mg or 200 mg plus MTX compared with patients receiving MTX alone.
Filgotinib 200 mg monotherapy inhibited the progression of structural damage at Week 24 compared with MTX alone as assessed by modified total Sharp score (mTSS).
Filgotinib in FINCH 3 Safety Profile
The safety profile of filgotinib in FINCH 3 is consistent with prior studies up to Week 24. Serious adverse events occurred in 4.1%, 2.4%, 4.8% and 2.9% of patients receiving filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg monotherapy and MTX alone, respectively. That’s why Gilead decided to file NDA for the approval of filgotinib.
A product that would work for rheumatoid arthritis when all other products stopp working becomes indispensable. Filgotinib’s results, as observed in clinical trials, make it the one that will be indispensable and a best seller. In the past few months Gilead signed solid scientific collaborations with highly scientific firms and had many positive clinical trial results.
We believe that Gilead has been for a long time in the oversold territory.
We also believe that the time has come to fairly evaluate this firm and benefit from it.
* * * * * * *
You might be asking why Karyopharm Therapeutics’ (KPTI) stock is UP 36% today.
You shouldn’t be. We did tell you the reason to expect a ferocious rebound several times before. Haven’t we?
To read more articles about these firms please run a search from our website by clicking here.