New drug for rheumatoid arthritis (RA)! Gilead's oral JAK1 inhibitor Jyseleca (filgotinib) is approved by the European Union and Japan!

!-- webeditor: page.title. -- -- Gilead and partner Galapagos NV recently jointly announced that the European Commission (EC) has approved Jyseleca (filgotinib, 200mg and 100mg tablets), an oral selective JAK1 inhibitor used to treat adult patients with moderate to severe rheumatoid arthritis (RA) who have inadequate or insatiable response to one or more disease-modified anti-rheumatoid drugs (DMARD).
drug use, Jyseleca can be used as a monotherapy or in combination with methotrexate (MTX).
On the same day, Gilead and Aedes aureus jointly announced that Japan's Ministry of Health, Labour and Industry (MHLW) had approved Jyseleca (200mg and 100mg tablets) for the treatment of RA patients who are under-responding to conventional therapies, including the prevention of structural joint injuries.
Under a cooperation agreement reached in December 2019, Gilead Japan holds jyseleca's sales license in Japan, and Aso will be responsible for dissecting the drug in Japan for the treatment of RA and other potential future adaptations, including ulcerative colitis, Crohn's disease, psoriasis arthritis, etc.
notable is that in the U.S. regulatory area, the FDA issued a full response letter (CRL) in August rejecting Jyseleca's approval.
THE FDA has requested data from MANTA and MANTA-RAy studies.
two studies have now been completed to assess whether filgotinib has an effect on sperm parameters, with topline results expected to be published in the first half of 2021.
, the FDA has expressed concern about the overall benefit/risk status of the 200 mg dose of filgotinib.
submitted the NDA to the FDA in December 2019, Gilead used a Priority Review Voucher (PRV) to expedite the review.
PRV was bought by Gilead from Ultragenyx for $80 million.
the CRL also means that $80 million is in the dolies.
rheumatoid arthritis (RA) is a chronic, aggressive, systemic, inflammatory disease that can cause severe and irreversible joint damage, pain and functional damage.
nearly 3 million RA patients in Europe, many of whom are unable to achieve long-term symptom control, which can lead to more frequent onset of symptoms and disease progress, seriously affecting quality of life.
treatments available, new treatments are needed to provide patients with effective symptom control and help best manage the impact of RA on their daily lives.
Jyseleca is a new JAK inhibitor with consistent safety throughout clinical development and proven strong symptom control and disease progression prevention.
clinical trial data show that Jyseleca showed clinical improvement, low disease activity, and clinical remission in a wide range of patient groups, including those who did not respond well to biologics.
approval of the drug will provide a welcome new option for RA patient groups in Europe and Japan.
rheumatoid arthritis (RA, pictured) Jyseleca was approved in the European Union and Japan, based on data from phase III FINCH and Phase II DARWIN programs, in which more than 3,500 patients received Jyseleca treatment, including first-time patients and patients with inadequate responses to biological DMARDs.
FINCH program includes three Phase III trials involving a wide range of RA patients, all of which reached their respective primary endpoints.
, Jyseleca consistently met the ACR20/50/70 target, with all individual ACR components showing improvement over placebo or MTX.
Compared to placebo or MTX, the proportion of patients treated with Jyseleca 200mg combined MTX or other conventional synthetic disease modified anti-rheumate drugs (csDMARD) achieved low disease activity and/or disease remission (DAS28-CRP-3.2 and DAS28-CRP 2.6) was significantly higher in weeks 12 and 24.
In patients with insufficient MTX response, an improved total Sharp score (mTSS) assessment was used in week 24, and the treatment of Jyseleca plus MTX had a statistically significant inhibitory effect on the progression of structural joint injuries compared to placebo-MTX.
ACR20/50/70 lasts up to three years in patients treated with Jyseleca 200mg monotherapy or in a joint treatment with MTX in DARWIN Phase 3 II Open Labeling, Long-Term Extension Studies.
trials of the FINCH and DARWIN projects, the four most common adverse reactions were nausea, upper respiratory tract infections, urinary tract infections, and dizziness.
of shingles and pneumonia is uncommon.
1.0% in the Jyseleca 200mg group and 0.6% in the placebo group.
in a comprehensive safety analysis of seven clinical trials, the risk of Jyseleca's major adverse heart events (MACEs) and venous thromboembolism (VTE) was comparable to that of placebos.
of serious infections remained stable as a result of long-term drug use.
the active pharmaceutical ingredient of Filgotinib molecular structure (Photo: Wikipedia) is filgotinib, a highly selective JAK1 inhibitor discovered and developed by Galapagos.
signed a $2 billion deal with Galapagos at the end of December 2015 to jointly develop filgotinib.
collaboration will help strengthen Gilead's position in the field of inflammatory diseases, which will also be a new growth point for Gilead in the future, following the hepatitis C and HIV sectors.
currently, Gilead and Galapagos are conducting a number of studies to assess Jyseleca's potential to treat a variety of inflammatory diseases, including Phase III studies including the treatment of rheumatoid arthritis, Crohn's disease, and ulcerative colitis.
a report by Evaluate Pharma, a pharmaceutical market research group, predicts that Jyseleca will be one of Gilead's key products driving future growth, with global sales expected to reach $1.4 billion by 2024.
!--/ewebeditor:page--!--ewebeditor:page title"--however, Jyseleca will also face a number of competing products in the JAK inhibitor space, with the exception of two listed Pfizer Xeljanz and Lilly Olumiant, the stronger rival will be Ebbvie's Rinvo.
, Rinvoq has been successfully approved by the United States and the European Union to treat moderate to severe rheumatoid arthritis (RA).
Evaluate Pharma had forecast sales of $2.57 billion in 2024 when Rinvoq companies go public.
Origin: European Commission Grants Marketing Authorization for Jyseleca® for The Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis !--/ewebeditor:page.