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    Home > Active Ingredient News > Drugs Articles > Drug curry research | In-depth review of 58 original innovative drugs first approved by the United States, Europe and Japan in 2020

    Drug curry research | In-depth review of 58 original innovative drugs first approved by the United States, Europe and Japan in 2020

    • Last Update: 2021-01-20
    • Source: Internet
    • Author: User
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    The United States is the world's largest drug market, and the vast majority of innovative drugs to the world's first stop.
    40 of the 53 new molecular entities (NDMs) or new biological drugs (BAs) approved by the U.S. Food and Drug Administration (FDA) in 2020 are the first products approved worldwide.
    In addition to the United States, Europe and Japan are also major markets for innovative drugs worldwide, and although the European Medicines Agency (EMA) and the Japanese Medicines and Medical Devices Agency (PMDA) have approved several new drugs, only 5 and 13 are global first-time approved products, respectively.
    the launch of the 58 new drugs will solve the problem of "no cure" for multiple diseases and will also provide a qualitative overflight of existing treatments.
    here, this paper will be the 58 new drug research and development process, clinical efficacy, market expectations and the future development of the pharmaceutical industry to briefly introduce and comment, for the vast number of colleagues to provide reference and reference.
    the full version of this article will be published in the 2021 journal Pharmaceutical Progress. Keywords: New Drug, FDA, EMA, PMDA Author Kai Shao Weijun: Deputy Director Pharmacist, Pharmaceutical Progress/Pharmaceutical Curry Vera columnist, has been engaged in product analysis projects, product line planning layout work for many years, joined The Pharmaceutical Group in 2019, as Director of Product Strategy and Director of Product Development Department.
    years has been keen on drug cutting-edge information tracking combing, international pharmaceutical policy and international pharmaceutical market research, in 2016 founded the research and development category of public number pharmaceutical industry, currently has a subscription readership of about 150,000 people.
    , the number of new drugs approved by the FDA has risen significantly over the past 20 years, with the number of new drugs approved in 2020 the second-highest on record after 2018.
    of the new drugs approved by
    in 2020, 38 are small molecular blood drugs, 12 are biological products and 2 are RNA drugs, 19 of which have been identified as breakthrough therapies, 31 have been identified as orphan drugs, and 27 have been prioritized.
    Of the 53 drugs, 40 are the world's first approved, four are new or new for older drugs, and sales of 11 products such as Trodelvy are expected to top $1 billion in five years, making them the market's "heavyweight bomb."
    1.Ayvakit (avapritinib) On January 9, the FDA approved Blueprint Medicines' avapritinib for the treatment of adult gastrointestinal mesothelioma patients who are positive for 18 mutations in the alpha platea derivative growth factor subject (PDGFRA) gene exon 18 mutation and cannot be surgically removed or metastasis.
    gastrointestinal mesothelioma is a relatively rare tumor, with 5,000-6,000 new cases in the United States each year, about 10 percent of which carry PDGFRA gene mutations.
    is the first targeted treatment for gastrointestinal mesothelioma with a mutation in the PDGFRA gene, and FDA approval is based on the results of a clinical study involving 43 patients (NCT02508532).
    43 patients in the group were all exon 18 mutations, of which 38 patients were PDGFRA D842V mutations.
    After receiving this treatment, the total remission (ORR) rate was 84%, of which the total remission (CR) rate was 7%, the partial remission (PR) rate was 77%, and 61% of patients had sustained remission for more than 6 months, while the total remission rate was as high as 89% in the patient subgroup with PDGFRA D842V mutation, of which the total remission rate was 8%, of which the partial remission rate was 82% and 59% was more than 6 months.
    57 per cent of treatment-related adverse reactions were reported, with the most common adverse reactions being anemia (17 per cent).
    market potential, EvaluatePharma (EVP) forecasts sales of $918 million in 2026.
    2.Tepezza (teprotumumab-trbw) On January 21, the FDA approved Horizon Therapeutics' teprotumumab for the treatment of thyroid eye disease.
    thyroid eye disease, also known as Graves eye disease, is a self-immune-related disease with an annual incidence rate of 19 per 100,000, with a lifetime risk of 3 per cent for women and 0.5 per cent for men.
    FDA approval of teprotumumab was based on the results of two clinical trials involving 170 patients, of which 71% of the teprotumumab treatment group (trial I, NCT01868997) and 83% (trial II, NCT03298867) had a drop of more than 2mm in eye protrusion, compared with 20% and 10% in the placebo group.
    Teprotumumab, the first drug approved for thyroid eye disease, has huge market potential, with sales of $476 million in the past two quarters, according to the company's third-quarter results, while EVP alone forecasts that the product will be $484 million in 2024.
    23, the FDA accelerated approval of Epizyme's tazemetostat for metastasis, local metastasis, or advanced epithelosarcoma treatments that cannot be surgically eradicated.
    is a very rare soft tissue tumor, less than one percent of soft tissue sarcoma, estimated to be only a few hundred patients in the United States.
    Tazemetostat is a methyl transferase inhibitor that blocks the activity of EZH2 methyl transferase, which in turn blocks the growth of cancer cells, and is the first drug approved for the disease.
    FDA's accelerated approval of this product is based on the results of an open-label clinical study (NCT02601950) involving 62 patients with metastasis or localized late-stage endosarcoma.
    After two 800mg treatments per day, the total remission rate was 15%, the medium progression-free survival (PFS) was 5.5 months, the medium total survival (OS) was 19.0 months, and the duration of continuous remission in 6 of the 9 patients who were relieved exceeded 6 months.
    addition to cortosarcoma, tazemetostat is also developing adaptations such as figillomanphomoma.
    market potential, EVP forecasts sales of $556 million in 2024.
    . Nexletol (bempedoic acid) On February 21, the FDA approved Esperion Therap's bempedoic acid for treatment of patients with cardiovascular disease with hemoglobin hypercholesterolemia or atherosclerosis that requires further reduction of lipoprotein (LDL-C) at the maximum dose of dietary control and statins.
    Bempedoic acid is an oral lipid-lowering drug that reduces the liver's synthesis of LDL-C by inhibiting the activity of adenosine triphosphate-citric acid lysase (ACL).
    FDA's approval of the listing is based on two random, double-blind clinical studies.
    In the first clinical trial (NCT02666664), 2,330 patients were receiving the maximum to-dosage of lipid-lowering therapy (maximum dose of statins or statins in combination with other drugs, but without the use of 40 mg or more simvastatin or On the basis of PCSK9 inhibitor patients), this product or placebo treatment was added on a 2:1 basis, and the results showed a 17% decrease in LDL-C levels compared to the baseline in the 12th week of this treatment group, compared with only 2% in the placebo group, achieving a statistically significant difference.
    the design and results of another clinical trial (NCT02991118) were similar to those of the previous trial, with the bempedoic acid and placebo therapy group's LDL-C levels dropping by 15% and 2%, respectively, compared to the baseline in week 12.
    market potential, while the product faces competition from PCSK9 inhibitors, more than 50 percent of patients in the U.S. are unable to effectively control blood lipids from statin insupercability or statin use alone, and EVP forecasts sales of $716 million in 2024.
    21 February, the FDA also approved the listing of CGRP monoantigene-related peptides (CGRP) in Lingbei for preventive treatment of migraines.
    approval of this product is based on the results of two clinical studies, in trial I (NCT02559895), 665 patients with precancerous migraines received a placebo, 100 mg or 300 mg treatment every three months, respectively, in a ratio of 1:1:1, the main endpoint of 1-3 months compared to the baseline of migraine attacks.
    results showed that the average number of days of migraine attacks decreased by 3.2 days, 3.9 days and 4.2 days compared to the baseline in patients in the placebo, 100 mg or 300 mg treatment group, respectively, and that the two dose groups of eptinezumab achieved statistically significant differences with the placebo group.
    in another clinical trial for chronic migraines (NCT02974153), a total of 1,072 patients were admitted to the group, and the trial was similar in design to the trial, which showed that placebo, 100 mg or 300 mg of the product were treated The average number of days of migraine attacks decreased by 5.6 days, 7.7 days and 8.2 days compared to the baseline, respectively, and the two dose groups of eptinezumab also achieved statistically significant differences with the placebo group.
    the market, CGRP targets are highly competitive after the FDA approved sales of only $404 million in 2024 from Novarma's Erenumab, Teva's Fremantle, Lilly's Galcanezumab and Biohaven's Rimrimegepant.
    27 February, the FDA approved Biohaven's oral CGRP inhibitor, Rimrimegepant, for acute treatment of migraines in adults.
    Rimegepant is different from CGRP monoantigen, which is positioned to treat pain quickly, and Biohaven has also made a mouth-breaking tablet to speed up the drug's effectiveness.
    FDA approved the listing of this product is based on a randomized, double-blind clinical study (NCT03461757) results, subjects received this product 75 mg (n-732) and placebo (n-734) treatment, the main endpoint is a single dose within 2 hours of painless patients response rate and self-specified most obvious symptoms (MBS, mainly fear of light, nausea, panic response rate).
    results showed that the painless response rate of the treatment group was 21.2%, the response rate of no most obvious symptoms was 35.1%, and the placebo group was only 10.9% and 26.8%, respectively, all achieving statistically significant differences.
    Another similarly designed multi-center clinical trial with 1,186 patients (NCT03237845) also confirmed the effectiveness of this product, with a painless response rate of 19.6% in the treatment group and 37.6% in the least obvious symptom response, compared with 12.0% and 25.2% in the placebo group.
    market potential, EVP forecasts sales of $868 million in 2024, as it is the first oral CGRP inhibitor and the market positioning is different from CGRP single resistance.
    7.Sarclisa (isatuximab-irfc) On March 2, the FDA approved Sanofi's isatuximab, a combination of pomadamine and dexamysund for multiple myeloma (MM) treatments that have been used in the past with more than two therapies, including pomadamide and protease inhibitors.
    Isatuximab is an Anti-CD38 antibody that plays a physiological role by inhibiting the activity of its ADP-ribosyl cyclase.
    a clinical trial called ICARIA-MM (NCT02990338) evaluated the safety and efficacy of this product with pomadamine and dexamisong.
    307 subjects were randomly grouped on a 1:1 basis, adding this product or placebo therapy on the basis of Pomadamine and dexamymethon therapy, respectively, and the results showed that the total remission rate of the treatment group was 60.4%, the medium PFS was 11.53 months, and the placebo group was only 35.3% and 6.47 months, respectively, and the middle OS had not yet reached 17.
    multiple myeloma is a relatively rare tumor, with 32,000 new cases and 1.3 deaths in the United States by 2020, according to the National Cancer Institute.
    Before the product was approved, the FDA had approved Johnson and Johnson's CD38 antibody daratumumab, which is more widely used than isatuximab and can be used for under-the-skin injection therapy, and is the strongest competitor to the product, with EVP forecasting sales of $516 million in 2024.
    . Zeposia (ozanimod) On March 25, the FDA approved Celgene's ozanimod for the treatment of adult multiple sclerosis (RMS), including clinical isolation syndrome, relapsed remission-relieving diseases, and active secondary progressive diseases.
    Ozanimod is a pyrethroid 1-phosphate (s1p) subject regulator with very high affinity with s1p subject 1 and 5, but the mechanism of role in multiple sclerosis is not yet fully clear.
    FDA approved the listing based on two randomized, double-blind, placebo-controlled clinical studies.
    Test One (((
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