2019 FDA: Approval of 42 new drugs 9 biosimilars 3 on the road

As of November 29, 2019, the FDA has approved 42 new drugs, 9 biosimilars, and three new drugs, PDUFA, in December, and 45 new drugs are expected to be approved by the FDA in 20192019 will be the lowest number of new drugs approved by the FDA compared to 2017 and 2018, but not badly, such as Skyrizi, Zolgensma, Rozlytrek and BrukinsaThis article summarizes 42 new drugs approved by the FDA in 2019, nine biosimilars, and three new drugs that faced FDA decisions in DecemberThe current FDA approves 42 new drugs, breaking a three-year low As of November 29, the FDA approved 42 new drugs in 2019, the FDA approved 57 and 62 new drugs in 2017 and 2018, respectively, 2019 can be said to be the FDA approved the new drug "a dismal" yearThe U.Sgovernment has experienced several suspensions from late 2018 to early 2019, and the resignation of former FDA Director Scott Gottlieb has caused shocks in the biopharmaceutical industry, which could affect approval of new drugsTable 1 As of November 29, 2019, the FDA approved 42 new drugs, although slightly inadequate in quantity, but not bad in quality, such as the most valuable new psoriasis drug Skyrizi gene therapy Zolgensma, broad-spectrum anti-cancer drug Rozlytrek and BacchiShenzhou's first FDA new drug Brukinsa, as well as the first in a number of disease areasOn April 23, 2019, the FDA approved leukocyte interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab-rzaa) for the treatment of moderate to severe plaque-like psoriasis in adultsPsoriasis, also known as psoriasis, is a common autoimmune diseaseAnalysts expect Skyrizi's annual sales to reach $3.196 billion in 2024, the most valuable new drug approved by the FDA in 2019Once approved, Skyrizi will enter a very crowded market with competitors such as Taltz, Siliq, Tremfya and IlumyaAmong them, Tremfya and Ilumya are selectively targeted IL-23 biological therapies similar to SkyriziSkyrizi is the best-performing of these drugs and will benefit the drug's market rollout, with significant phase III clinical studies resulting in a 90 percent improvement in psoriasis immunity and severity index (PASI) among patients treated with SkyriziIn addition, Skyrizi's advantage is not only in efficacy, but also in its ease of useAfter the first use of Skyrizi, the second is four weeks after the patient's second injection, and after that patient only needs to be injected four times a year, while Tremfya needs to be injected every 8 weeks, and the patient is trained to inject Skyrizi on his ownGene therapy Zolgensma - The most expensive drug in history, May 24, 2019, FDA approved gene therapy Zolgensma to be available for treatment in children under 2 years of age with sMN1 isocontira-induced spinal muscular dystrophy (SMA), at a one-time cost of $2.125 millionZolgensma is a one-time gene replacement therapy that introduces the normal SMN1 gene into the patient through type 9 adenovirus (AAV9) to replace the defective SMN1 gene, which can effectively synthesize the functioning SMN protein Zolgensma (AVXS-101) has advantages in terms of efficacy and cost-effectiveness over Spinraza, another SMA gene therapy previously approved by the FDA Spinraza and Zolgensma's Treatment Ideas - The third broad-spectrum cancer drug Rozlytrek announced on August 15, 2019 that it has accelerated approval of Roche's development of Rozretinib to treat adult and adolescent cancer patients with NTRK gene fusion who have no other effective treatment Rozlytrek is a specific tyrosine kinase inhibitor designed for NTRK and ROS1 gene fusion that inhibits TRK A/B/C and ROS1 kinase activity Rozlytrek was first approved in Japan in June to treat patients with advanced recurrent solid tumors with NTRK gene fusion Rozlytrek Molecular (pictured from Wikipedia) Rozlytrek is the fda-approved third wide-spectrum anti-cancer therapy for "unlimited cancer" after Keytruda and Vitrakvi, targeting specific genetic characteristics that drive cancer rather than the type of tissue in which the tumor originated On Thursday, BeiGenes announced that Brukinsa (Zebutinib) had received accelerated FDA approval to treat patients with adult cell lymphoma (MCL), who had previously received at least one treatment, the first chinese-grown anti-cancer drug to be approved for sale in the United States, rewriting the embarrassing history of China's anti-cancer drug 'only can't get into' Brukinsa, a small molecule inhibitor of Bruton's tyrosine kinase (BTK), developed by Baiji Shenzhou, is currently conducting a wide range of critical clinical trials around the world to treat a wide range of B-cell malignancies as a single drug and in combination with other therapies Two new drug listing applications (NDA) for the treatment of patients with recurrent/r-incurable (R/R) MCL and R/R chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL) have been prioritized by NMPA First product in multiple fields: 1) Egaten (Novartis): On February 13, 2019, the FDA approved the launch of egaten, the first treatment for tablet-like sepsis, for the treatment of patients over 6 years of age 2) Zulresso (Sage Therapeutics): On March 19, 2019, the FDA approved the launch of Zulresso, the first new drug for postpartum depression (PPD) 3) Vyndaqel (Pfizer): On May 3, 2019, the FDA approved the launch of Vyndaqel, the first new drug for the treatment of attritic inamylogenic myopathy (ATTR-CM) 4) Turalio (Daiichi Sankyo): On August 2, 2019, the FDA approved The first and only approved drug for the treatment of tendon cytoma (TGCT) 5) Xenea Therapeutics: On August 19, 2019, the FDA approved the first intravenous and oral antibiotic Xenleta with a new mechanism in nearly two decades, the first community-acquired bacterial pneumonia (CABP) 6) Reblozyl (Celgene and Acceleron): On November 8, 2019, the FDA approved the first new drug for the treatment of beta-thalassemia, Reblozyl, which is found mainly in coastal Mediterranean countries and countries in Southeast Asia, and is high in the southern region of our country 7) Givlaari: On November 20, 2019, the FDA approved the launch of Givlaari, the first new drug for the treatment of acute hepatic disease (AHP) in adults, and Givlaari has been recognized by EMA and FDA orphan drugs, qualified for the EMA rapid approval process, and fda breakthrough therapy Significant progress in a number of areas: 1) Mayzent (Novartis, 2019-03-26): The first and only FDA-approved treatment for active progressive multiple sclerosis (SPMS) in the past 15 years 2) Pretomanid (TB Alliance, 2019-08-14): The third new drug against tuberculosis approved by the FDA in nearly 40 years and the first new tuberculosis drug developed and marketed by a non-profit organization 3) Inrebic (Celgene, 2019-08-16): The first new bone marrow fibrosis drug in nearly a decade 4) Aklief (Galderma, 2019-10-04): The first Fda-approved vitamin A molecule for acne use in more than two decades 5) Reyvow (2019-10-11): The first new class of acute migraine treatmentapproved by the FDA in more than two decades Three new diagnostic drugs: 1) Ga-68-DOTATOC (Advanced Accelerator Applications, 2019-08-21): it consists of posmatoprosin (Somatostatin, SST) analogue DOTATOC, which can be used to diagnose neuroendocrine tumors (neurots, NETs) 2) Fluorodopa F 18 (The Feinstein Institutes for Medical Research, 2019-10-10): A radiological diagnostic reagent used in positron emission tomography (PET) to visualize dopamine nerve endings in brain striatum to assess suspected Parkinson's adult patients 3) ExEm Foam (Giskit B.V., 2019-11-07): Used to assess the fallopian tube function of women diagnosed or suspected of infertility 9 biosimilars, 2 more than last year As of November 29, 2019, the FDA has approved 25 biosimilars, and 9 biosimilars have been approved so far in 2019, two more than in 2018, demonstrating the FDA's efforts to continue to promote competition in biologics and bring biosimilars to the market Biosimilars are highly similar to FDA-approved biological products (reference biologicalproducts) and do not differ significantly clinically The original products approved by the FDA in 2019 are concentrated in Roche, AbbVie and Agmen, Roche: Herceptin (Ontruzant, Trazimera, Kanjinti), Avastin (Zirabev), Rituxan (Ruxience); AbbVie: Hadi, Abrilada; Agmen: Enbrel (Zibre, Neuva Of all 25 biosimilars approved by the FDA, five are Humira, five Herceptin, two Enbrel, two Avastin, three Remicades and three Neulasta biosimilars Because the FDA and EMA treat biosimilars and the patent protection of primary drugs in different forms, the development of biosimilar drugs in the European Union is growing rapidly, in the United States is slow, not all FDA-approved biosimilars can be sold Table 2 As of November 29, 2019, the FDA approved 25 biosimilars If these three products are successfully launched, the number of new FDA approvals for new drugs in 2019 could be 45 Table 3 Ubrogepant, a new, efficient, oral calcitonin-related peptide (CGRP) receptor antagonist developed by Allergan in December 2019, is currently developed for the treatment of acute migraines To date, three monoantigen migraine drugs targeting CGRP receptors have been on the market: Aimovig (erenumab-aooe, Amgen), Ajovy (fremanezumab-vfrm, Teva), Andenature (galcanezumab-gnlm, Eli Lilly) Compared to the first 3, Ubrogepant was used as a post-symptom drug, the other three were preventive medications, Ubrogepant was taken orally, the other 3 were subcutaneous injections, and Ubrogepant was more convenient Vascepa (Twenty Carbon Pentecostae) capsules, a high-purity EPA (20-carbon pentaenic acid) single-molecule prescription product derived from deep-sea fish through a rigorous, complex, FDA-regulated production process, were approved by the FDA in 2012 for the use of complementary treatments in the diet of patients with severe adults (-500 mg/dL) of patients with high triglycerides to reduce their triglyceride levels Based on the results of the 2018 REDUCE-ITTM trial, Amarin submitted a new application for a new drug to reduce cardiovascular risk to the FDA in March 2019 On May 29, 2019, the FDA has formally accepted Vascepa's application for a supplementary new drug (sNDA) for cardiovascular risk indications, and has granted priority review status Lumateperone is the first small molecule drug developed by Intra-Cellular Therapies (ICT) to selectively regulate the three neurotransmitter pathways of serotonin, dopamine and glutamate, which involve serious diseases Lumateperone may be effective in a range of mental symptoms, improves psychosocial function and good tolerance, and may benefit patients with a range of neuropsychiatric disorders and neurodegenerative diseases Currently, applications for a new drug for the treatment of schizophrenia are being reviewed by the FDA ICT is also developing Lumateperone to treat other mental disorders, including behavioural disorders in people with dementia, Alzheimer's disease, depression and other neuropsychiatric and neurological disorders Source: 1 FDA Official Website 2 Before 2019 closes, the FDA has 3 key approval decisions to make