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Gather the safety of JAK inhibitors!

 Last Update: 2021-07-28
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News on July 22, 2021 // - Pfizer (Pfizer) announced today that the US Food and Drug Administration ( the FDA ) has informed the company will not be (PDUFA) target date "Prescription Drug User Fee Act" for a new generation of oral JAK1 inhibitor abrocitinib (100 mg, 200mg) New Drug Application (NDA) for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents (≥12 years old), the oral JAK inhibitor Xeljanz/Xeljanz XR (tofacitinib, tofacitinib) for the treatment of adult activity Supplemental New Drug Application (sNDA) for ankylosing spondylitis (AS) made a review decision
.

Pfizer FDA new generation oral JAK1 inhibitor abrocitinib oral JAK inhibitor Xeljanz/Xeljanz XR (tofacitinib, tofacitinib)

FDA reference, the agency is carried out after the listing Pfizer ORAL Surveillance studies reviewed, the study is evaluating oral Jtofacitinib (tofacitinib) inhibitor treatment with TNF severe class arthritis Security (RA) in adults Sex
.
The review of the results of the study was a factor in the delay of the drug review
.
According to the notice on April 7, 2021, the FDA has previously extended the PDUFA target date to the beginning of the third quarter of 2021
.

FDA Rheumatoid Arthritis FDA

Dr.
Michael Corbo, Chief Development Officer of Inflammation and Immunology, Pfizer Global Product Development , said: "We still have confidence in the benefit-risk profile of abroctinib and Xeljanz.
Both drugs have been proven in robust clinical trials
.
Many patients with moderate to severe atopic dermatitis or active ankylosing spondylitis have limited treatment options
.
We look forward to news from the FDA as we are working hard to bring these important potential treatment options to suitable patients
.
"

Immunology clinical trials FDA

It is particularly worth mentioning that, in addition to the two JAK inhibitors mentioned above by Pfizer, the FDA has recently taken AbbVie's oral JAK1 inhibitor Rinvoq (upadacitinib) for the treatment of sNDA in moderate to severe AD adult patients, and Eli Lilly's oral JAK1 inhibitor Olumiant ( Chinese trade name: Ai Leming, common name: baricitinib, baritinib) sNDA for the treatment of moderate to severe AD adult patients has issued a postponement notice
.

FDA AbbVie oral JAK1 inhibitor Rinvoq (upadacitinib) Eli Lilly oral JAK1 inhibitor Olumiant Eli Lilly

All these delays are related to the ongoing safety review of JAK inhibitors by the FDA
.
JAK inhibitors are a promising class of therapeutic methods can be used to treat a variety of autoimmune diseases, but these drugs due to safety issues has been questioned
.

All these delays are related to the ongoing safety review of JAK inhibitors by the FDA
.
FDA autoimmune

In January of this year, Pfizer announced the preliminary co-primary endpoint results of the post-marketing safety study ORAL Surveillance (A3921133, NCT02092467)
.
Data show that the study did not reach the non-inferiority predetermined criteria: The major adverse cardiovascular events (MACE) and malignant tumors (excluding non- melanoma skin cancer [of NMSC]) aspect, Xeljanz secure than TNF inhibitor
.

Post-marketing safety study ORAL Surveillance tumor melanoma Xeljanz is less safe than TNF inhibitors
.

And other tofacitinib (tofacitinib) different studies, ORAL Surveillance study specifically to assess cardiovascular events and malignant tumor risk , thus requiring subjects aged 50 years or older, and at least one additional cardiovascular screening when Risk factors (for example, current smoking, high blood pressure , high cholesterol levels, diabetes , history of heart attack, family history of coronary heart disease, extra-articular rheumatoid arthritis disease)
.
In addition, all subjects were also required to receive insufficient response to background methotrexate treatment to qualify for the study
.
Currently, Pfizer is continuing to work with the US FDA and other regulatory agencies to review all results and analysis
.

Specifically evaluate cardiovascular events and malignant tumors of the risk of tumor hypertension, diabetes Currently, Pfizer is continuing with the US FDA collaboration and other regulatory bodies to review the full results and analysis
.
FDA

ORAL Surveillance study preliminary co-primary endpoint results (click the picture to see the larger picture)

Abrocitinib is an oral small molecule that can selectively inhibit Janus kinase 1 (JAK1)
.
Inhibition of JAK1 is believed to regulate a variety of cytokines involved in the pathophysiological process of atopic dermatitis (AD), including interleukin (IL)-4, IL-13, IL-31, IL-22 and thymic stromal lymphocyte production Plain (TSLP)
.
In the United States, the FDA granted abrocitinib a breakthrough therapy designation (BTD) for the treatment of moderate to severe atopic dermatitis (AD) in February 2018
.

abrocitinib is an oral small molecule that can selectively inhibit Janus kinase 1 (JAK1) FDA

The application of abrocitinib for the treatment of moderate to severe AD is based on data from the robust Phase 3 JADE global clinical development project
.
In this project, compared with placebo, abrocitinib showed statistical superiority in skin lesion removal, disease range and severity, and the pruritus symptoms were also rapidly improved (as early as the second week)
.
Abrocitinib also showed consistent safety in trials and was generally well tolerated
.

The active pharmaceutical ingredient of Xeljanz/Xeljanz is tofacitinib (tofacitinib), which is an oral JAK inhibitor that can selectively inhibit JAK kinase and block the JAK/STAT pathway, which is a signal stimulated by cytokines Transduction pathways are involved in many important biological processes such as cell proliferation, differentiation, apoptosis and immune regulation
.

Xeljanz was approved in the United States in 2012 and is the first JAK inhibitor on the market .
The drug is taken orally twice a day
.
Currently, Xeljanz in the United States has been approved for four indications: (1) treatment of moderate to severely active class rheumatoid arthritis (RA) adult patients; (2) the treatment of active psoriatic arthritis (PsA) Adult patients; (3) Treatment of adult patients with moderate to severe ulcerative colitis (UC); (4) Treatment of children and adolescents with juvenile idiopathic arthritis (pcJIA) ≥2 years old with active polyarticular disease course
.

Xeljanz was approved in the United States in 2012 and is the first JAK inhibitor rheumatoid arthritis to be marketed

Since 2012, Xeljanz has conducted research in more than 50 clinical trials worldwide , including more than 20 trials for RA patients, and more than 300,000 adult patients worldwide (most of them are RA patients) A prescription was issued
.
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Clinical Trials

Original source: Pfizer Provides Update on US FDA Review of Abrocitinib and XELJANZ® Filings

Pfizer Provides Update on US FDA Review of Abrocitinib and XELJANZ® Filings

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