New drug for rheumatoid arthritis! Gilead JAK inhibitor filgotinib was rejected by the FDA, $80 million to buy the coupon into a bubble!

August 19, 2020 // -- Gilead recently announced that the U.S. Food and Drug Administration (FDA) has issued a full response letter (CRL) to the new drug application (NDA) for filgotinib (200mg and 100mg tablets).
the drug is an oral selective JAK1 inhibitor used to treat adult patients with moderate to severe active rheumatoid arthritis (RA).
it's worth noting that Gilead also used a Priority Review Voucher (PRV) to expedite the review when it submitted the NDA to the FDA in December 2019.
PRV was bought by Gilead from Ultragenyx for $80 million.
the CRL also means that $80 million is in the dolies.
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 top-line 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.
We are disappointed with the FDA's results and we will evaluate the key points mentioned in the CRL for discussion with the FDA," said Dr. Merdad Parsey, chief medical officer of Gilead.
we remain convinced of the therapeutic benefits/risks of filgotinib in rheumatoid arthritis, as demonstrated in the FINCH III Clinical Project.
" is currently under review by regulators around the world.
The European Union, at the end of July this year, the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) issued an active review recommending the approval of Jyseleca (filgotinib, 100mg and 200mg tablets) for the treatment of moderate to severe RA adult patients who do not respond well to one or more disease-modified rheumosic drugs (DMARD).
positive comments have been submitted to the European Commission for review, which is expected to make a decision in the third quarter of this year.
Filgotinib NDA is based on 52 weeks of data from the Global Phase III FINCH Clinical Project.
the project assessed the efficacy and safety of filgotinib in 3,452 patients with moderate to severe active RA.
In these studies, filgotinib reached its primary endpoint and demonstrated long-lasting efficacy and long-term safety in a wide range of RA patient groups, including patients who previously had inadequate responses to methotrexate (MTX), patients who were not resistant to one or more biological agents, and patients who had not previously received MTX therapy (MTX primary treatment).
in patients with RA in different sub-groups, daily oral filgotinib treatment improved clinical signs and symptoms, achieved low disease activity and treatment mitigation, and inhibited structural damage.
results are consistent throughout the FINCH program, further enhancing the long-term safety and toerability of filgotinib in a wide range of RA patient groups.
of the
filgotinib molecular structure (Photo: Wikipedia) Although treatments are currently available, patients with rheumatoid arthritis (RA) may face persistent symptoms of the disease and inadequate response to existing treatments.
one in five patients who do not receive complete disease remission in their lifetime still need treatment.
is 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.
cooperation 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 the potential of filgotinib to treat a variety of inflammatory diseases, including Phase III studies including the treatment of RA, Crohn's disease, and ulcerative colitis.
report by Evaluate Pharma, a pharmaceutical market research group, predicts that filgotinib will be one of Gilead's key products for future growth, with global sales expected to reach $1.4 billion in 2024.
, however, in the JAK inhibitor space, filgotinib will also face a number of competing products, in addition to the two listed products Pfizer Xeljanz and Lilly Olumiant, the stronger opponent will be AbbVie's Rinvoq .
, 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.
() Original source: Gilead Receives Complete Response Letter for Filgotinib for The Treatment of Moderately to Severely Active Rheumatoid Arthritis.