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    Home > Medical News > Medical World News > Lilly VEGFR Inhibitor Portfolio approved Pfizer releases clinical results for oral JAK1 inhibitors.

    Lilly VEGFR Inhibitor Portfolio approved Pfizer releases clinical results for oral JAK1 inhibitors.

    • Last Update: 2020-08-03
    • Source: Internet
    • Author: User
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    AstraZeneca announced that Brilinta has been approved in the United States to reduce the risk of first-time heart attack or stroke in patients with high-risk coronary heart disease (CAD), the most common type of heart disease. This is the first time that regulators have approved aspirin jointly for Grillo, a double antiplatelet treatment for patients with high cardiovascular (CV) risk but no history of heart attack or stroke. The drug was first approved by the FDA on July 20, 2011 for use in patients with acute coronary artery syndrome (ACS), to reduce the incidence of thrombosis cardiovascular events, and on November 22, 2012 by the China Drug Administration approved for reducing thrombosis in patients with acute coronary syndrome (unstable angina, non-segment ST elevated myocardial infarction or ST section elevated myocardial infarction).
    FDA approval is based on the positive results of Phase 3 clinical trial SIS. The trial showed a statistically significant reduction in the primary compound endpoint of major adverse cardiovascular events during the 36-month combination of aspirin and Grillo compared to those with coronary heart disease and type 2 diabetes (T2D) who had a high risk of first heart attack or stroke. The main compound endpoint is a decrease in heart attack and stroke.
    THEMIS is a multi-country, randomized double-blind Phase 3 clinical trial designed to test the hypothesis that the combination of degrillor and aspirin reduces the risk of major adverse cardiovascular events (MACE). The THEMIS trial, launched in early 2014, is one of the largest randomized trials ever conducted in people with type 2 diabetes. CAD is defined as transdermal coronary artery interventional therapy (PCI), bypass surgery, or coronary artery stenosis of at least 50%. THE THEMIS TRIAL SHOWED THAT IN CAD AND T2D PATIENTS WITH NO HISTORY OF HEART ATTACK OR STROKE, ASPIRIN COMBINED LONG-TERM GRILLO THERAPY REDUCED THE RELATIVE RISK OF HEART ATTACK, STROKE AND CV DEATH COMPOUND ENDPOINT BY 10% (ABSOLUTE RISK REDUCTION; 0.8%, 7.7% VS 8.5%) COMPARED TO ASPIRIN MONODRUG TREATMENT.
    Lilly announced that the U.S. FDA has approved the company's Cyramza (ramucirumab) and erlotinib, a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor 19 or exomer 21 (L858R) mutation. With this approval, Cyramza has now received six FDA approvals for the treatment of certain types of lung, liver, stomach and colorectal cancers.
    Cyramza in conjunction with Elottinib is the first FDA-approved, first-line treatment for metastatic EGFR mutation serotonin cancer, VEGFR/EGFR tyrosine kinase combination therapy. This approval is based on efficacy and safety data from RELAY, a global, randomized, placebo-controlled Phase 3 clinical trial.
    in the RELAY study, Cyramza (vascular endothelial growth factor receptor 2 antagonists) was used in conjunction with elottinib (EGFR inhibitor) to provide statistically significant and clinically significant improvements in patients' progression-free survival. The PFS in the Cyramza combination therapy group was 19.4 months and the control group was 12.4 months. (HR.59; CI, 0.46, 0.76;
    RELAY is the second Phase 3 clinical trial in Cyramza to treat metastatic non-small cell lung cancer. The first is REVEL, which supports the approval of Cyramza United Dositacy as a treatment for patients with metastatic non-small cell lung cancer, whose cancer continues to progress after receiving platinum chemotherapy.BioMarin Pharmaceuticals,
    , announced the latest results of its research gene therapy valococogene roxaparvovec for the treatment of severe haemophilia in adults, in open label 1/2 clinical studies. Long-term follow-up results showed that patients still did not need to receive other preventive therapy four years after receiving one gene therapy. The data has been presented as an updated summary at the World Hemophilia Alliance (WFH) Virtual Summit, to be held from June 14 to 19 this year. The application for this gene therapy is currently under review by the FDA and the EUROPEAN Union EMA.
    Valoctocogene roxaparvovec is a genetically modified gene therapy that uses AAV5 virus vectors to deliver expression factor VIII. The advantage is that patients may only need to receive one treatment and liver cells can consistently express factor VIII, thus avoiding the need for long-term preventive coagulation factor injections. The treatment has been approved by the FDA for breakthrough therapy and THE EUROPEAN Union-awarded PRIME drug recognition, as well as the EMA and FDA-granted orphan drug qualification. Doubts about this gene therapy, however, are how long it will last. The latest clinical data provide more information in this regard. The press release noted that this is one of the longest follow-up results of gene therapy for haemophilia to date.
    the latest trial results show that patients treated with gene therapy at a dose of 6e13 vg/kg and patients receiving a dose of 4e13 vg/kg gene therapy have not received preventive coagulation factor VIII since receiving valococogene roxaparvovec after a single dose. The follow-up time for these patients was 4 years and 3 years, respectively.
    in the 4years following treatment, the average annual haemorrhage rate (ABR) in the 6e13 vg/kg queue was 1.3, and in the third year of gene therapy, the average ABR of the 4e13 vg/kg queue was 0.5. In the past year, 6 out of seven participants in the 6e13 vg/kg queue did not experience spontaneous bleeding. Five of the six participants in the 4e13 vg/kg queue still did not experience spontaneous bleeding. Although the activity level of coagulation factor VIII decreased in the blood of patients, the decrease was comparable to the observations of recent years and remained within the range of providing hemostatic effect.
    Lilly announced that the U.S. FDA has approved the il-17A antagonist Taltz (ixekizumab) extended indication strain developed by the company to treat patients with active non-radiology spinal arthritis (nr-axSpA) patients with inflammatory non-radiation symptoms with inflammatory objective symptoms. The approval makes Taltz the first FDA-approved IL-17A antagonist for nr-axSpA, the press release said.
    Taltz was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque-like psoriasis. Subsequently, it was approved for treatment in adult patients with active psyllitary arthritis (PsA), as well as aggressive spina bifida.
    The safety and efficacy of Taltz was confirmed in a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study that included active nr-axSpA adult patients with objective inflammatory symptoms. The main endpoint of the study was the proportion of patients who reached ASAS40 at the 52st week. The results showed that the proportion of Taltz patients who reached the primary endpoint was better than the placebo, with 30% of the patients treated with Taltz (80 mg) receiving asAS40 every 4 weeks, compared with 13% of those treated with placebo (P-0.0045). The main secondary endpoint was the ASAS40 response at week 16, with 35 percent of the patients in the Taltz group reaching that endpoint, compared with 19 percent of the placebo group (P 0.01).
    Sanofi, inc., announced that its anti-CD38 antibody Sarclisa (isatuximab), in conjunction with the standard treatment of Kafizomi and Disemison (Kd), reached the primary endpoint in phase 3 clinical trials for patients with recurrent multiple myeloma (MM). The Sarclisa combination reduced the risk of disease progression or death by 47% compared to standard treatments consisting of kafizomi and dexamethasone (HR-0.531, p-0.0007, n-179). The Sarclisa combination showed consistent treatment benefits in multiple subgroups compared to Kd's individual treatment.
    Sarclisa is a monoclonal antibody that binds to a specific epilaston on CD38 receptors on MM cells. It works through a variety of mechanisms, including procedural tumor cell death (apoptosis) and immunomodulation of activity. CD38 is highly uniformly expressed on the surface of MM cells, making it a potential target for antibody-based therapeutic drugs such as Sarclisa.
    the randomized, multicenter, open-label phase 3 clinical trial, called IKEMA, enrolled 302 recurrent MM patients in 69 centers in 16 countries. At the time of mid-term analysis, the median progression-free survival (PFS) in the Kd treatment group was 19.15 months, while the median PFS was not reached in patients receiving sarclisa combination therapy.
    at the same time, the total remission rate (CR) in the Sarclisa combination therapy group was 39.7% and the standard treatment group was 27.6%. In 29.6% of patients in the Sarclisa combination treatment group and 13% of patients in the standard treatment group received the smallest residual lesions (MRD) negative total remission, indicating that nearly 30% of patients receiving Sarclisa combination therapy were unable to detect MM presence through next-generation sequencing (NGS).
    Y-mAbs Therapeutics announces that the company's BiologicS License Application (BLA) for GD2 antibody naxitamab has been accepted and granted priority review status by the FDA, and that the adaptation is for patients with recurrent/refractive high-risk neuroblastoma. The FDA is expected to respond by November 30. The FDA also said it does not plan to hold an advisory committee meeting to discuss the application.
    Naxitamab is a human-derived monoclonal antibody that targets GD2 antigens. GD2 antigens are expressed on the surface of tumors generated by the neuroblastogerin layer, including neuroblastoma, melanoma, and osteosarcoma. By binding to the GD2 antigen on the tumor surface, Naxitamab can trigger the cytotoxic response of the antibody vector and activate the complement system in the immune system, thus achieving the effect of killing tumors. It has been qualified by the FDA for orphan editing for neuroblastoma and osteosarcoma, and breakthrough therapy has been identified as a combination of GM-CSF for the treatment of high-risk neuroblastoma.
    the application was based on positive data from a Phase 1/2 clinical trial called 12-230. Of the first group of neuroblastoma children in the trial, 28 patients who were not eligible for induced chemotherapy with a recurrent/difficult-to-treat high risk were treated with a combination of naxitamab and GM-CSF, and more than half of them had difficulty receiving second-line chemotherapy. Trial data showed that the therapy resulted in an objective remission rate (ORR) of 78 percent in patients and a progression-free survival (PFS) of 50 percent of patients to 24 months. In the second group of patients, 30 patients who received salvage therapy but did not perform well received combination therapy naxitamab and GM-CSF, and one-third of the patients had relapsed more than twice, and 89 percent had been treated with anti-GD2 drugs. Trial data showed that the treatment resulted in an ORR of 37% in patients and a 24-month PF in 36% of patients.
    Pfizer Inc. announced that the full results of the second critical phase 3 clinical trial for the treatment of specific dermatitis, a JAK1 inhibitor, developed by the company, were released on JAMA Dermatology. Abrocitinib is a research oral JAK1 inhibitor (once daily) used in patients aged 12 and over with moderate to severe adhesion dermatitis (AD). Consistent with the first phase 3 single drug therapy study, both doses of abrocitinib reached all common primary and critical secondary endpoints and were well tolerated.
    Pfizer's abrocitinib is an oral small molecule-specific JAK1 inhibitor. JAK1 inhibitors control the condition by regulating a variety of cytokines associated with the pathology of ad hoc dermatitis, including leukocyte interleukin IL-4, IL-13, IL-31, and interferon. Previously, abrocitinib has been approved by the FDA for breakthrough therapy.
    JADE MONO-2 is a randomized, placebo-controlled parallel group study designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg, once a day) of abrocitinib monodrug therapy for 12 weeks, with a total of 391 patients participating in this clinical trial.
    trial results showed that both doses of abrocitinib significantly improved dermatitis symptoms compared to placebo using a number of different symptom detection methods.
    Biogen published the company's Phase 2 clinical data on the treatment of patients with lepunosus (CLE) in the research monotherapy BIIB059 at the European Rheumatology Congress (EULAR 2020). BIIB059 is an all-human source IgG1 monoclonal antibody that targets blood dendritic cell antigen 2 (BDCA2). BIIB059 is currently being developed to treat patients with CLE and systemic lupus. BDCA2 is a receptor that is the only expression in human immune cell plasma cell-like dendritic cells (pDC), which reduces the production of inflammatory cytokines, including type I interferon (IFN-I), and plays an important regulatory role in the pathological mechanism of lupus. The results showed that BIIB059 significantly improved disease symptoms compared to the placebo group.
    randomized double-blind, placebo-controlled phase 2 LILAC study, called LILAC, enrolled a total of 264 participants, including active CLE and SLE patients. In the study section on the treatment of CLE patients, 132 patients were treated with different doses of BIIB0059.
    trial results showed that patients treated with BIIB059 at 16 weeks were treated with a CLASI-A score using the clASI-A score.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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