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    Home > Active Ingredient News > Drugs Articles > Further postponement: Eli Lilly/Incyte Baritinib's new indication listing application has been delayed, and JAK inhibitors are hit again

    Further postponement: Eli Lilly/Incyte Baritinib's new indication listing application has been delayed, and JAK inhibitors are hit again

    • Last Update: 2021-07-17
    • Source: Internet
    • Author: User
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           April 6, 2021, Lilly and Incyte announced that the US FDA has extended its JAK inhibitor Barry imatinib , a new indication for listing application (sNDA) (Olumiant®) for moderate to severe atopic dermatitis The review period
    .
    This is another JAK inhibitor that encountered obstacles after the sNDA of Gilead filgotinib (Jyseleca®) and AbbVie upadacitinib (Rinvoq®) was postponed

    .
    Let's take a look at the reasons .

           Jyseleca: Application for indications for moderate to severe active rheumatoid arthritis (RA) rejected

           In August 2020, Gilead announced that the FDA issued a complete response letter (CRL) for the new drug application of filgotinib (Jyseleca®, 200mg and 100mg tablets), requesting data from the MANTA and MANTA-RAy studies
    .
    These two studies have now completed patient recruitment, aiming to evaluate whether Jyseleca has an impact on sperm parameters.
    The top-line results are expected to be announced in the first half of this year

    .
    In addition, the FDA also expressed concerns about the overall benefit/risk profile of the 200mg dose of Jyseleca

    .
    Affected by this, Gilead has announced the suspension of the Phase III clinical study of Jyseleca in psoriatic arthritis, and the Phase II clinical study of ankylosing spondylitis and uveitis

    .

           Jyseleca is an oral selective JAK inhibitor for the treatment of adult patients with moderate to severe RA
    .
    Jyseleca NDA is based on 52 weeks of data from the global phase III FINCH clinical project

    .
    The project evaluated the efficacy and safety of Jyseleca in 3452 patients with moderately to severely active RA

    .
    In these studies, Jyseleca reached the primary endpoint and showed long-lasting efficacy and long-term safety in a broad group of RA patients, including patients who had previously insufficiently responded to methotrexate (MTX), and were resistant to one or more organisms.
    Patients who are intolerant of the preparation, patients who have not previously received MTX treatment (MTX-initial treatment)

    .
    Among RA patients in different subgroups, oral administration of Jyseleca once a day can improve clinical signs and symptoms, achieve low disease activity and therapeutic relief, and inhibit structural damage

    .

           Rinvoq: Delayed review of indications for psoriasis and atopic dermatitis

           Rinvoq is a once-a-day, selective and reversible JAK inhibitor developed by AbbVie for a variety of immune-mediated inflammatory diseases.
    The drug has a stronger inhibitory effect on JAK1 and JAK2, JAK3 and TYK2

    .

           On March 17, 2021, the FDA extended the review period for Rinvoq to treat adult patients with active psoriatic arthritis (PsA) supplementary new drug applications.
    The updated Prescription Drug User Fee Act (PDUFA) action date has been extended by three months.
    Until the end of the second quarter of 2021

    .
    As of the afternoon of March 17, AbbVie's stock price fell more than 6% to $104.
    18

    .

           The drug was successful in a large-scale phase III clinical study for the treatment of adult psoriatic arthritis last year.
    The study was based on the activity of insufficient or intolerant response to one or more non-biological disease-modifying anti-rheumatic drugs (DMARDs).
    Psoriatic arthritis develops in adult patients

    .

           This is a multicenter, randomized, double-blind, parallel-group, positive-drug and placebo-controlled Phase III study, conducted in 1705 adult PsA patients with insufficient response to at least one non-biological DMARD, and evaluated 2 doses The efficacy and safety of Rinvoq (15mg and 30mg, once a day) relative to placebo and adalimumab
    .
    In the study, patients were randomly assigned to receive Rinvoq 15mg, Rinvoq 30mg, Adalimumab (40mg, every other week [EOW]), and placebo

    .
    The primary endpoint was the proportion of patients who achieved an ACR20 response in the two-dose Rinvoq treatment group compared with the placebo group at week 12

    .
    Secondary endpoints include: the change in the Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 12 from baseline, the proportion of patients who reached PASI 75 (psoriasis area severity index improved by 75%) at week 16, and the lowest disease at week 24 Proportion of patients with degree of activity (MDA)

    .

           The data showed that the study reached the primary endpoint: in week 12, 71% and 79% of patients in the 15mg group and 30mg group achieved ACR20 responses, respectively, and 36% in the placebo group (p<0.
    0001)

    .
    When compared with adalimumab, the two doses of Rinvoq achieved non-inferiority in the ACR20 response rate at the 12th week of treatment, and only the 30 mg dose showed superiority

    .
    In terms of the ACR50 response rate at the 12th week of treatment, the 15mg group, 30mg group, and placebo group were 38%, 52%, and 13%, respectively (nominal p<0.
    0001)

    .
    In terms of ACR75 response rates at the 12th week of treatment, the 15 mg group, 30 mg group, and placebo group were 16%, 25%, and 2%, respectively (nominal p<0.
    0001)

    .

           In August 2019, Rinvoq received the world's first batch in the United States for moderate to severely active rheumatoid arthritis (RA) adult patients with insufficient or intolerance to methotrexate
    .
    Rinvoq has also been approved by the European Commission for the treatment of adult patients with moderate to severe RA who have insufficient or intolerant response to one or more disease-modifying anti-rheumatic drugs (DMARDs) to treat the activity that occurs in such adult patients.
    Psoriatic arthritis and active ankylosing spondylitis (AS)

    .

           The industry was very optimistic about Rinvoq's business prospects
    .
    However, on April 2, the FDA took another postponement measure for another supplementary new drug listing application for Rinvoq (moderate to severe atopic dermatitis) and required AbbVie to update its benefit/risk data

    .

           As a JAK inhibitor, Rinvoq's safety flaws have greatly hindered the release of its market potential
    .

           Olumiant: Delayed review of indications for atopic dermatitis

           On April 6, 2021, the FDA announced the delay of the review period of an sNDA for Olumiant for moderate to severe atopic dermatitis.
    The PDUFA date was extended to the beginning of the third quarter of 2021

    .

           Olumiant is also a JAK inhibitor, which was approved by the FDA as early as June 2018 for rheumatoid arthritis
    .
    At the same time, according to the information in the instructions, the FDA issued a black box warning on the potential safety hazards of Olumiant's serious infection, malignant tumor and thrombosis

    .

           Atopic dermatitis is a chronic, recurrent, inflammatory skin disease.
    Its etiology is affected by environmental factors and genetic factors.
    Because patients often have other atopic diseases such as allergic rhinitis and asthma, it is considered to be a kind of Systemic immune diseases

    .

           Olumiant is a selective and reversible JAK1 and JAK2 inhibitor that is taken orally once a day.
    Its main active ingredient is baricitinib.
    It is the world's first JAK inhibitor approved for the treatment of atopic dermatitis (AD)

    .

           It is worth mentioning that, as a highly potential innovative drug, Olumiant has been continuously creating surprises since its launch.
    It is not only approved for the treatment of inflammatory dermatitis, but also for a variety of inflammatory diseases and autoimmune diseases.
    treatment, such as rheumatoid arthritis, psoriasis, diabetic nephropathy, systemic lupus erythematosus and the like

    .

           The purpose of the sNDA delay is to allow time to review additional data analysis submitted by Eli Lilly in response to the FDA’s recent information request
    .

           Among the development of many targeted therapies, JAK is one of the most popular targets
    .
    JAK inhibitors are still in full swing at home and abroad, with great potential and market
    .
    However, the development of JAK inhibitors still faces challenges, and the problems of safety and tolerability need to be solved urgently.
    If highly selective inhibitors are successfully developed, it is expected to reduce potential risks and give birth to more new-generation therapies

    .

           Reference source:

           1.
    Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis;

           2.
    AbbVie Announces Extension of Review for Supplemental New Drug Application of Upadacitinib for the Treatment of Adults with Active Psoriatic Arthritis;

           3.
    RINVOQ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis;

           4.
    FDA extends review period for Rinvoq sNDA;

           5.
    https://investor.
    lilly.
    com/news-releases/news-release-details/lilly-and-incyte-communicate-review-extension-supplemental-new;

           6.
    https://endpts.
    com/another-day-another-delay-fda-pushes-back-a-second-review-for-abbvies-rinvoq-this-time-in-atopic-dermatitis/.
           

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