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

AstraZeneca announced that Brilinta (D-Guerrero) 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 regulators have approved aspirin jointly for Grillo, a double antiplatelet treatment for patients at high cardiovascular (CV) risk but without a history of heart attack or stroke.
the drug was approved by the FDA as early as July 20, 2011 for use in patients with acute coronary artery syndrome (ACS), to reduce the incidence of thrombosis cardiovascular events, november 22, 2012 approved by the Chinese Drug Administration, for acute coronary syndrome (unstable angina, non-ST section elevated myocardial infarction or ST section of myocardial infarction) patients, to reduce the incidence of cardiovascular thrombosis.
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 heart attack and stroke reduction.
THEMIS is a multi-country, randomized double-blind Phase 3 clinical trial designed to test the hypothesis that the combination of degrillor and aspirin can reduce the risk of major adverse cardiovascular events (MACE). The
THEMIS trial, launched in early 2014, is one of the largest randomized trials to date among people with type 2 diabetes.
CAD is defined as meritotic coronary artery interventional therapy (PCI), bypass surgery, or coronary artery stenosis of at least 50%.
OFIS trials showed that in CAD and T2D patients with no history of heart attack or stroke, aspirin combined with 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 therapy.
"kill" a specific lung cancer! Lilly, the FDA-approved combination of VEGFR inhibitors, announced that the FDA has approved the company's Cyramza (ramucirumab) and erlotinib, a first-line treatment accompanied by epidermal growth factor receptor (EGFR) epithematal 19 missing or exosome 21 (L858R) mutation of metastatic non-small lung cancer (NSC) patients.
approval, Cyramza has now received six FDA approvals for 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 therapeutic 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 urlotinib (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-0.59; CI, 0.46, 0.76; p?lt;0.0001).
RELAY is the second Phase 3 clinical trial in Cyramza to treat metastatic non-small cell lung cancer with positive results.
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.
follow-up for up to 4 years! The long-term efficacy of type A haemophilia gene therapy BioMarin Pharmaceuticals announced the latest results of its research gene therapy valocococogene roxaparvovec for the treatment of severe haemophilia in adults, in open label 1/2 clinical studies.
long-term follow-up results showthat patients still do not need to receive other preventive therapy four years after receiving one gene therapy.
data has been presented as the latest summary to the World Hemophilia Alliance (WFH) Virtual Summit, which will be held from June 14 to 19 this year.
application for the 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.
its 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.
doubt, however, is about how long the gene therapy will last.
the latest clinical data provide more information in this regard.
press release, 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 those receiving a dose of 4e13 vg/kg gene therapy have not received preventive coagulation factor VIII since receiving valococogene roxaparvovec after a single dose.
follow-up time for these patients was 4 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, six of the 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 patients
, the decrease was comparable to that observed in recent years and remained within the range of providing hemostatic effect.
sword finger middle axis spinal arthritis! Lilly's IL-17A inhibitors have been approved by the FDA for Lilly, inc. announced that the FDA has approved the company's development of the IL-17A antagonist Taltz (ixekizumab) extended indications to treat patients with active non-radiology-intra-inflammatory spinal arthritis (nr-axSpA) patients with inflammatory objective symptoms.
press release noted that the approval makes Taltz the first FDA-approved IL-17A antagonist for nr-axSpA.
Taltz was first approved by the FDA in March 2016 for the treatment of moderate to severe plaque-like psoriasis.
subsequently, it was also approved for treatment in adult patients with active psyllitary arthritis (PsA), as well as aggressive spinabitis.
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 week 52.
trial 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 the ass40 every 4 weeks, compared with 13% of those treated with a placebo (P-0.0045). The primary secondary endpoint of
was the ASAS40 response at week 16, with 35 percent of the patients in the Taltz group reaching that endpoint, compared with 19 percent in the placebo group (P-lt;0.01).
reduce the risk of disease progression in MM patients by nearly 50%! Sanofi's CD38 antibody portfolio has been highlighted by Sanofi," which has been linked to the standard treatment of Kafizomi and Dicemimon (Kd), and has reached the primary end point in a phase 3 clinical trial 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).
Sarclisa combination showed consistent treatment benefits in multiple subgroups compared to Kd's individual treatment.
Sarclisa is a monoclonal antibody that binds to specific epitope on CD38 receptors on MM cells.
its role through a variety of mechanisms, including programmed tumor cell death (apoptosis) and immunomodulation 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.
as 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.
, the total remission rate (CR) in the Sarclisa combination therapy group was 39.7% and the standard treatment group was 27.6%.
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).
"capture" refractive neuroblastoma! Innovative GD2 Antibodies Fda Priority Review Qualification 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 the adaptation is for patients with recurrent/difficult-to-treat high-risk neuroblastoma.
FDA is expected to respond by November 30.
FDA also said it does not plan to hold an advisory committee meeting to discuss the application.
Naxitamab is a humanized monoclonal antibody that targets GD2 antigens.
GD2 antigen expression on the surface of the tumor generated in the neuroblastogenic layer, including tumors such as neuroblastoma, melanoma, and osteosarcoma.
Naxitamab, by binding to the GD2 antigen on the tumor surface, can trigger the cytotoxic response of the antibody vector and activate the immune system complement system, thus achieving the effect of killing the tumor.
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.
in 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 in combination with naxitamab and GM-CSF, and more than half of them had difficulty receiving second-line chemotherapy.
trial data show that the treatment 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, with one-third of the patients having relapsed more than twice and 89% having 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.
release of full Phase 3 clinical results! Pfizer's oral JAK1 inhibitorsignificantly relieves dermatitis symptoms Pfizer announced that the full results of the second critical Phase 3 clinical trial of the JAK1 inhibitor abrocitinib for the treatment of teratomatitis developed by the company was published in JAMA Dermatology.
Abrocitinib is a research oral JAK1 inhibitor (once a day) used in patients aged 12 and over with moderate to severe adhesional 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. Before
, abrocitinib had been approved by the FDA for breakthrough therapy.
, MONO-2, a randomized, placebo-controlled parallel group study designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg, once daily) of abrocitinib monodrug therapy for 12 weeks, with a total of 391 patients participating in this clinical trial with moderate to severe adhesional dermatitis.
test results show.