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    Home > Active Ingredient News > Drugs Articles > Six drugs have been approved by CHMP of European Union. AstraZeneca and Roche occupy two seats respectively

    Six drugs have been approved by CHMP of European Union. AstraZeneca and Roche occupy two seats respectively

    • Last Update: 2017-10-17
    • Source: Internet
    • Author: User
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    Source: Sina medical 2017-10-17 European Drug Administration (EMA) human pharmaceutical products Committee (CHMP) recently held a review meeting in October, recommending and approving 6 drugs for expanding indications, including: (1) alecensa (alectinib), Roche targeted anticancer drug; (2) bydureon (exenatide), an AstraZeneca GLP-1 receptor agonist and hypoglycemic drug Er, exenatide sustained release); (3) rubicin (daptomycin, daptomycin); (4) AstraZeneca breast cancer drug (fulvestrand, fluvectin); (5) Pegasys (Pegatron alfa-2a, pegylated interferon α - 2A), a new generation of oral prostate cancer drug zytiga (enzalutamide, abitrone acetate) In addition, CHMP also recommended approval of tacrolimus, a generic drug from Teva, for the prevention and treatment of transplant rejection The drug was originally developed by advagraf (tacrimus), a transplant rejection drug from the Japanese pharmaceutical company anstar (1) Specifically, CHMP recommends alecensa as a single drug therapy for adult patients with ALK positive advanced NSCLC, and CHMP recommends that alecensa's conditional approval for second-line treatment of ALK positive NSCLC be changed to full approval CHMP recommended alecensa for first-line treatment, based on data from phase III clinical study Alex This study is a randomized, multicenter, open label study in 303 adult patients with treatment naive ALK positive nscnc The purpose of this study is to compare the efficacy and safety of alecensa and Pfizer targeting anticancer drug xalkori (crizotinib) in the first-line treatment The results showed that alecensa significantly reduced the risk of progression or death (PFS) by 53% (HR = 0.47, 95%) compared with xalkori CI: 0.34-0.65, P < 0.001), which significantly reduced the risk of brain metastasis or central nervous system (CNS) metastasis or brain / CNS tumor growth by 84% (HR = 0.16, 95% CI: 0.10-0.28, P < 0.001); in the study, although alecensa treatment lasted for a long time (17.9 months vs 10.7 months), it showed more favorable safety and tolerance Alecensa is a new small molecule tyrosine kinase inhibitor (TKI) targeting ALK In the United States and the European Union, the drug obtained accelerated approval and conditional approval in December 2015 and February 2017, respectively As a single drug therapy, it is used for the second-line treatment of adult patients with ALK positive advanced NSCLC who have received xalkori treatment before Recently, the FDA has also granted alecensa the priority qualification for first-line treatment of ALK positive NSCLC ALK positive NSCLC is common in younger and nonsmoking lung cancer populations, especially in specific types of NSCLC known as adenocarcinoma It is estimated that most of the patients with ALK positive NSCLC will develop drug resistance within one year after receiving the current standard nursing drug xalkori, and about 60% of them will have central nervous system (CNS) metastasis Studies have shown that alecensa is able to maintain its activity in CNS through the blood-brain barrier, so the drug is also effective against brain metastases (2) Bydureon combined with basic insulin for the treatment of type 2 diabetes mellitus (T2D) Specifically, CHMP recommends that bydureon combined with other hypoglycemic drugs (including basic insulin) be approved for the adult patients with type 2 diabetes who can not fully control blood glucose level through exercise and diet restriction, so as to improve blood glucose control; Bydureon was approved for marketing in 2012 and is the first weekly drug approved for the treatment of type 2 diabetes; it is a human glucagon like peptide-1 receptor agonist (glp-1ra), a drug that mimics intestinal glucagon, and human glucagon like peptide-1 The effect of GLP-1 is similar, it can promote Glucose dependent insulin secretion, inhibit inappropriate Glucose dependent glucagon secretion, slow gastric emptying, improve the sensitivity of peripheral tissue to insulin, and fully control blood glucose It should be noted that bydureon cannot be treated with type 1 diabetes (T1D) or diabetic ketoacidosis Bydureon can't replace insulin either (3) In particular, CHMP recommends approval of Cubicin for SAB in adult patients and pediatric patients (1-17 years old): in adult patients, bacteremia should be related to right heart infective endocarditis (RIE); in pediatric patients, bacteremia should be related to complex skin and soft tissue infection (cssti) Cubicin is a kind of cyclic lipopeptide antibiotic, which has strong antibacterial effect on Gram-positive bacteria Cubicin is administered intravenously In the European Union, the approved indications of Cubicin include: (a) adult patients with cssti and pediatric patients (1-17 years old); (b) adult patients with RIE caused by Staphylococcus aureus infection When formulating the medication strategy, we need to consider the antibiotic susceptibility and refer to the expert opinion; (c) adult patients with SAB Cupicin is a heavy-duty antibiotic product developed by cupist, an antibiotic giant, with an annual sales volume of more than US $1 billion Cubist is a global leader in the field of antibiotics Over the past 20 years, cubist has been committed to developing new antibiotics to treat serious life-threatening infectious diseases and solve global public health problems At the end of 2014, msdh invested $9.5 billion to acquire Cubist and acquired related products and pipeline assets The acquisition will combine Cubist's expertise in the field of global antibiotics with MSD's strong strength and global influence, so that MSD can create a more favorable position in the field of hospital emergency care, while addressing unmet medical needs in key areas, such as antibiotic resistance (4) For postmenopausal women with ER + locally advanced or metastatic breast cancer, the CHMP recommends approval of faslodex as a single drug therapy For the treatment of postmenopausal women with ER + locally advanced or metastatic breast cancer, including those who have not received endocrine therapy before, those who have relapsed during or after adjuvant anti estrogen therapy, or those who have progressed during Anti estrogen therapy; (b) in combination with palbociclib (c) in premenopausal or perimenopausal women, the combination of faslodex and palbociclib should be combined with luteinizing hormone releasing hormone (LHRH) agonist In the European Union and the United States, faslodex was approved as a single drug therapy in August and September 2017, respectively, for the first-line treatment of ER + / her2-advanced breast cancer patients who have passed menopause and have not received endocrine therapy Faslodex is the only hormone drug for the treatment of advanced breast cancer It can delay the growth of tumor by binding and degrading estrogen receptor In some patients, estrogen receptor is a key driver of breast cancer progression At present, faslodex has been widely approved for the treatment of HR + postmenopausal women with advanced breast cancer after the treatment of anti estrogen drugs Faslodex was first approved for marketing in 2002 Currently, AstraZeneca is testing the therapeutic potential of more than 19 faslodex combinations for HR + patients with advanced breast cancer Breast cancer is the most common malignant tumor in women Advanced breast cancer (ABC) refers to stage III and stage IV breast cancer Stage III is also known as local advanced stage, while stage IV refers to metastatic breast cancer, which is also the most advanced stage Cancer cells have spread from the breast to other parts of the body At present, there are no drugs to cure advanced breast cancer In clinical, the treatment goal of advanced breast cancer is to delay the deterioration or death of the disease (5) Specifically, CHMP recommends Pegasys for children and adolescents with HBeAg positive chronic hepatitis B (CHB) who are 3 years old or older without cirrhosis and who have evidence of viral reversion and have sustained elevated serum ALT levels Pegasys is a pegylated interferon alpha-2a, long-acting interferon, which has been approved for the treatment of CHB and chronic hepatitis C (CHC) In the treatment of CHB, pegays is suitable for adult patients with HBeAg positive or HBeAg negative CHB with evidence of compensatory liver disease and viral replication, elevated ALT and histologic evidence of liver inflammation and / or fibrosis In the treatment of CHC, Pegasys is suitable for: (a) combined with other antiviral drugs for adult patients with CHC accompanied by compensatory liver disease; (b) combined with ribavirin (RBV), for children and adolescents with CHC who are at least 5 years old in primary treatment (treatment naive) and whose serum HCV-RNA is positive The growth inhibition induced by combination therapy should be considered when children start treatment (6) In particular, CHMP recommends approval of zytiga combined with prednisone or prednisolone, combined with androgen deprivation therapy (ADT), for the newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in adult men In the European Union, zytiga has been approved for the following indications: (a) combination of prednisone or prednisolone for asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mcrpc) adult male patients who have failed ADT treatment and whose chemotherapy effect has not been clinically confirmed; (b) combination of prednisone or prednisolone for the duration of docetaxel chemotherapy regimen or Adult male patients with mcrpc developed after treatment Zytiga is a CYP17 inhibitor, which can inhibit the key enzyme regulating androgen production, and androgen can stimulate the growth of prostate cancer cells Zytiga can reduce the androgen level of prostate cancer cells, which is the current goal of prostate cancer treatment Zytiga is the world's best-selling prostate cancer treatment drug, with sales of up to $2 billion 260 million in 2016 At present, zytiga's main competitors are xtandi (enzalutamide) developed by anstelai in cooperation with medivation.
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