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    Home > Active Ingredient News > Drugs Articles > New drugs approved by the FDA from January to August 2020.

    New drugs approved by the FDA from January to August 2020.

    • Last Update: 2020-09-27
    • Source: Internet
    • Author: User
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    From January to August 2020, the FDA approved 38 new drugs for sale and eight in August.
    : The new drugs listed here mainly refer to FDA-approved new molecular entities, new biological products, cell therapies, gene therapies, excluding vaccines.
    : 1.avapritinib Product Name: Ayvakit Company: Blueprint Medicines January 9, FDA Approves Blueprint Medicines Company's Ayvakit (avapritinib) for the treatment of small blood carriers In patients with non-surgical or metastasis adult gastrointestinal mesothelioma (GIST) mutations of the plate-source growth factor-absorbed alpha (PDGFRA) gene 18 exons, the most common type of 18 exon jump mutations was also included in the D842V bit mutation.
    Avapritinib is an oral, highly active and highly selective KIT and PDGFR alpha inhibitor.
    a variety of diseases with KIT and PDGFR alpha mutations (including KIT D816V, PDGFR alpha D842V and KIT exon 17 mutations) have poor response to standard therapies and lack effective treatment methods, and avapritinib has shown good preclinical activity against these mutations.
    GIST is a type of tumor that originates in the interlegaste tissue of the gastrointestinal tract and accounts for the majority of inter-digestive leaf tumors.
    GIST can occur anywhere in the digestive tract, most commonly in the stomach and small intestine, and the molecular mechanism is caused by mutations in the activation of the Tyrosine kinase protein gene KIT (CD117) or plateboard-based growth factor-like factor alpha (PDGFR alpha) gene activation.
    about 6% of newly diagnosed patients carry the PDGFA exon 18 mutation.
    2.teprotumumab-trbw Product Name: Tepezza Inc.: Horizon Therapeutics January 21, FDA approves Horizon Therapeutics' Teprotumumab-trbw listing for the treatment of thyroid eye disease.
    is the first FDA-approved drug for thyroid eye disease.
    TED is an autoimmune disease that often occurs in patients with meldonium, which is usually manifested in eye protrusiveness, complex vision, blurred vision and facial deformities.
    the disease is mainly caused by the patient's autoantibodies activating the insulin-like growth factor 1 subject (IGF-1R) in the eye frame.
    Teprotumumab is a monoclonal antibody targeting IGF-1R, and Phase III OPTIC clinical studies have shown that patients treated with Teprotumumab significantly reduce eye protrusion (82.9% vs 9.5%) and reach the main endpoint.
    , patients treated with the drug had an effect on reducing resopsis and improving quality of life, reaching the secondary end point.
    safety, most adverse reactions in the Teprotumumab treatment group are mild to moderate and can be controlled.
    3.tazemetostat: Tazverik Inc.: Epizyme On January 24, the FDA approved Epizyme Inc.'s Tazverik (tazemetostat) for the treatment of metastasis/localized late epitheliotic sarcoma adult patients and pediatric patients over 16 years of age.
    -like sarcoma is a rare soft tissue sarcoma, which is found in young adults between the ages of 20 and 40, and is more common in men.
    currently, the main treatment options are surgical excision, chemotherapy or radiotherapy.
    is the first FDA-approved EZH2 inhibitor and the first FDA-approved sarcoma treatment.
    Phase II clinical study showed that patients treated with Tazemetostat had ORR of 15%, of which CR was 1.6% and PR was 13%.
    , 67 percent of all patients who responded had a continuous response time of 6 months or more.
    safety, 37% of patients in the Tazemetostat treatment group experienced severe adverse reactions.
    of these patients had severe adverse reactions, mainly bleeding, chest fluid build-up, skin infections, breathing difficulties, pain and respiratory distress.
    1 patient (2%) were permanently deactivanted due to adverse reactions to mood changes.
    4.lactitol: Pizensy Inc.: Braintree Labs On February 12, the FDA approved the launch of TheIntree Lab-developed Pizensy (lactitol) for the treatment of adult patients with chronic idiopathic constipation (CIC).
    CIC is a disease characterized by difficulty detocation, indesocisity, and bloating of abdominal pain, which affects about 35 million people in the United States.
    currently, drugs, including laxatives, are clinically used to relieve patients' symptoms to a certain extent, but they also lead to drug dependence.
    Pizensy is an oral lactose therapy that is a permeable laxative that promotes water into the intestines and thus achieves a general urination effect.
    a randomized, double-blind, placebo-controlled multi-center clinical trial showed that the Pizensy treatment group reached 25 percent and 13 percent of patients in the placebo group who achieved three total spontaneous detops (CSBMs) or at least one increase in baseline ratios in a week, reaching the primary endpoint.
    safety, common adverse reactions are upper respiratory tract infections, bloating, diarrhea, elevated blood creatinine kinase, bloating and elevated blood pressure.
    5.bempedoic acid Product Name: Nexletol Inc.: Esperion February 21, the FDA approved Esperion Inc.'s Nexletol tablet to be marketed as an auxiliary diet and maximum tolerable dose of statins for the treatment of adult hemolytic familial hypercholesterolemia (HeFH) patients, or for patients with atherosclerosis (ASCD) who need to further reduce LDL-C.
    Nexletol is the first oral non-statin-lowered LDL-C drug approved once a day since 2002.
    bempedoic acid is a synthetic ddiometric acid derivative, an ATP-citric acid lysate (ACL) inhibitor of first in class, which reduces LDL-C by inhibiting biosynthetic cholesterol in the liver and raising the LDL-R.
    FDA's approval of Nextletol is based on the results of a series of key phase III projects worldwide in more than 3,000 patients.
    Aggregation analysis of clinical trials in four of these patients, which totaled more than 2,600 patients, showed that bempedoic acid combined with moderate or maximum toned dose statins reduced LDL-C by a further 18 percent after placebo correction, and bempedoic acid combined with low-dose statins or without statins, which reduced LDL-C after placebo correction by a further 21 to 28 percent.
    In Phase III clinical studies, bempedoic acid was well-ptically suitable, the incidence of common adverse events was similar to that of the placebo group, and the most common (-2%) and higher adverse events in the placebo group included upper respiratory tract infections, muscle spasms, high uric acidemia, back pain, abdominal pain or mild discomfort, bronchitis, anemia, elevated liver enzymes, etc.
    the severity of adverse events, most of the bempedoic acid group was light to moderate, similar to the placebo group.
    .eptinezumab-jjmr Product Name: Vyepti Inc.: Lingbei Pharmaceuticals On February 21, the FDA approved the listing of Eptinezumab-jjmr for the prevention of migraines in adults.
    the first intravenous drug approved by the FDA to prevent migraines.
    Vyepti is a calcitonin gene-related peptide (CGRP) drug acquired by Lingbei in its $1.95 billion acquisition of Alder, which is considered an important neuropeptide associated with migraines.
    efficacy and safety of Vyepti were confirmed in two randomized, double-blind, placebo-controlled clinical studies.
    , the PROMISE-1 study focused on patients with seizure migraines, and the PROMISE-2 study focused on patients with chronic migraines.
    results showed that Vyepti reached the primary endpoint of reducing the average number of migraine days per month (MMD) in patients for 1-3 months in both studies.
    in a separate safety study involving 2,076 patients, Vyepti's most common adverse reactions were nasopharyngitis and hypersensitive reactions.
    7.amisulpride Product Name: Barhemsys Company: Acacia Pharma February 27, FDA approves Acacia Pharma's Barhemsys (amisulpride) to be listed as a single drug or combination of other therapies to treat and prevent postoperative nausea and vomiting symptoms (PONV).
    is the first postoperative nausea and vomiting remedial therapy approved for patients who have previously failed to prevent it.
    PONV is a common complication of surgery, which occurs in about 30 percent of surgical patients and 80 percent of high-risk patients.
    PONV is associated with the use of anaesthetic gases or analgesia drugs and is more common after gynecological, abdominal, breast, eye and ear operations, especially among operations that last for an hour or more.
    of patient surveys, PONV was listed as one of the most serious symptoms of surgical complications, even more so than pain.
    Barhemsys is a selective dopamine D2 and D3 subject antagonist.
    efficacy and safety of Barhemsys have been confirmed in 4 Phase III clinical studies.
    , a clinical study involving patients who failed to prevent standard anti-spitting therapy showed that the Barhemsys treatment group was significantly more effective than the placebo group (42% vs. 29%).
    another clinical study involving high-risk patients with PONV showed that Barhemsys combined with another anti-spitting drug significantly due to the effectiveness of placebo-combined anti-spitting drugs (58% vs. 47%).
    8.rimegepant: Nurtec ODT Inc.: Biohaven On February 27, the FDA approved Biohaven's Nurtec oral disintegration tablet for the treatment of acute migraines in adults.
    Rimegepant is an oral disintegration tablet (ODT) that disintegles quickly in the mouth without water (or with only a small amount of water present), enters the digestive tract with swallowing action, and absorbs no mucous membranes in the mouth.
    , compared with ordinary preparations, ODT has the advantages of easy to take, fast absorption, high bio-utilization, small irritation to the mucous membranes of the digestive tract, etc., which has been widely concerned.
    FDA's approval of Rimegepant is based on the results of a key Phase III clinical trial (Study 303) and a long-term Open Label Safety Study (Study 201).
    In the Study 303 study, there was a statistically significant statistical difference between reaching the common primary endpoint of pain-free and most annoying symptoms (MBS) two hours after taking rimegepant compared to placebo, and Rimegepant showed statistical advantages in relieving pain (reducing moderate or severe pain to painless or mild pain) and restoring normal function within 1 hour.
    for most patients, pain freedom, pain relief, normal function and the benefits of getting rid of MBS lasted 48 hours.
    importantly, these benefits can be seen in just 1 dose of rimegepant.
    86% of patients who took rimegepant did not need first aid drugs (e.g. NSAIDS, acetaminophen) within 24 hours of administration.
    Study 201 study assessed the safety and toaling of long-term multiple-dose rimegepant.
    the study assessed 1,798 patients with migraine attacks who took 75mg of rimegepant as needed and up to one dose a day.
    the study included 1,131 patients exposed to rimegepant for at least six months and 863 patients exposed to at least one year, all of which had at least two migraine episodes per month on average, but the study has not determined the safety of Rimegepant's 15 migraine attacks in 30 days.
    in clinical studies, less than 1% of the subjects experienced respiratory difficulties and hypersensitive reactions to severe rashes, including severe hypersensitive reactions delayed after drug delivery.
    9.isatuximab Product Name: Sarclisa Company: Sanofi March 2, FDA approves Sanofi's CD38 single anti-drug Sarclisa (isatuximab-irfc) listing, Recurring refractic multiple myeloma (MM) adult patients who have received at least 2 lines or more of therapy in the past for combined pomadamine and dexamymethon therapy, including lysine and a protease inhibitor.
    is the second FDA-approved CD38 antibody drug in the world after Johnson and Johnson Darzalex (Daretoyu monoanti) to promote the programmed death of tumor cells by targeting specific tables of CD38 receptors on multiple myeloma cells.
    2019, Darzalex's sales reached $2,998 million.
    approval is based on ICIARI.
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