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July 26, 2020 // Gilead and partner Galapagos NV jointly announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued a positive review recommending approval of oral selective JAK1 inhibitors Jyseleca (filgotinib, 200mg and 100mg tablets) is used in adult patients with moderate to severe rheumatoid arthritis (RA) who have inadequate response to anti-rheumosis drugs (DMARD) for one or more diseases.
's positive views of CHMP will now be reviewed by the European Commission (EC), which has the power to approve medicines from 27 EU countries, Norway, Iceland, Liechtenstein and the UK.
expects the committee to make a decision in the third quarter of 2020.
CHMP's active review, based on data from Phase III FINCH and II DARWIN projects.
FINCH project consists of 3 Phase III trials involving a wide range of RA patients, all of which reached their primary endpoints.
trial, filgotinib consistently met ACR20/50/70 and other related treatment indicators, such as DAS28 (CRP) 2.6.
compared to placebo, filgotinib also inhibited the progression of structural joint injury assessed by the Improved Total Sharp Score (mTSS).
in the FINCH and DARWIN trials, the daily filgotinib showed consistent clinical safety in single-drug therapy or in combination with methotrexate (MTX). The incidence of severe infections and shingles in
is usually similar to that of Adamizumaand and methotrexate, while the incidence of major adverse heart events (MACE) and venous thromboembolism (VTE) is rarely reported.
filgotinib molecular structure (Photo: Wikipedia) filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos.
Gilead reached a $2 billion deal with Galapagos at the end of December 2015 to jointly develop filgotinib.
this partnership 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 areas of hepatitis C and HIV.
currently, Gilead and Galapagos are currently conducting a number of studies to assess the potential of filgotinib to treat a variety of inflammatory diseases, including phase III studies that include the treatment of rheumatoid arthritis, Crohn's disease, and ulcerative colitis.
pharmaceutical market research firm Evaluate Pharma has previously forecast that filgotinib will be one of Gield's key products for future growth, with global sales expected to reach $1.4 billion by 2024.
, however, filgotinib will also face a number of competing products in the field of JAK inhibitors, with the exception of two listed products, Pfizer Xeljanz and Lilly Olumiant, and a stronger rival to AbbVie's Rinvoq (upadacitinib).
currently, Rinvoq has successfully received u.S. and European Union approvals for the treatment of moderate to severe rheumatoid arthritis (RA).
, Evaluate Pharma, had forecast sales of $2.57 billion in 2024 when Rinvoq goes public.
() Original source: Gilead and Galapagos Announce Positive European CHMP Opinion for Jyseleca ® (Filgotinib) for the Treatment of adults With Moderate to Rheumatoid Arthritis.
