Literature DB >> 33864098

A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020.

Gizem Kayki-Mutlu1, Martin C Michel2.   

Abstract

While the COVID-19 pandemic also affected the work of regulatory authorities, the US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades. Most newly approved drugs related to oncology (34%) and neurology (15%). We discuss these new drugs by level of innovation they provide, i.e., first to treat a condition, first using a novel mechanisms of action, and "others." Six drugs were first in indication, 15 first using a novel mechanism of action, and 32 other. This includes many drugs for the treatment of orphan indications and some for the treatment of tropical diseases previously neglected for commercial reasons. Small molecules continue to dominate new drug approvals, followed by antibodies. Of note, newly approved drugs also included small-interfering RNAs and antisense oligonucleotides. These data show that the trend for declines in drug discovery and development has clearly been broken.

Entities:  

Keywords:  FDA; First-in-class; First-in-indication; New drugs

Year:  2021        PMID: 33864098     DOI: 10.1007/s00210-021-02085-3

Source DB:  PubMed          Journal:  Naunyn Schmiedebergs Arch Pharmacol        ISSN: 0028-1298            Impact factor:   3.000


  85 in total

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Journal:  Lancet       Date:  2019-11-14       Impact factor: 79.321

4.  Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer.

Authors:  Aditya Bardia; Ingrid A Mayer; Linda T Vahdat; Sara M Tolaney; Steven J Isakoff; Jennifer R Diamond; Joyce O'Shaughnessy; Rebecca L Moroose; Alessandro D Santin; Vandana G Abramson; Nikita C Shah; Hope S Rugo; David M Goldenberg; Ala M Sweidan; Robert Iannone; Sarah Washkowitz; Robert M Sharkey; William A Wegener; Kevin Kalinsky
Journal:  N Engl J Med       Date:  2019-02-21       Impact factor: 91.245

5.  Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: A systematic review and meta-analysis of randomized placebo-controlled trials.

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Journal:  Dermatol Ther       Date:  2020-12-11       Impact factor: 2.851

6.  Risdiplam in Type 1 Spinal Muscular Atrophy.

Authors:  Giovanni Baranello; Basil T Darras; John W Day; Nicolas Deconinck; Andrea Klein; Riccardo Masson; Eugenio Mercuri; Kristy Rose; Muna El-Khairi; Marianne Gerber; Ksenija Gorni; Omar Khwaja; Heidemarie Kletzl; Renata S Scalco; Timothy Seabrook; Paulo Fontoura; Laurent Servais
Journal:  N Engl J Med       Date:  2021-02-24       Impact factor: 91.245

7.  Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study.

Authors:  Ghassan K Abou-Alfa; Vaibhav Sahai; Antoine Hollebecque; Gina Vaccaro; Davide Melisi; Raed Al-Rajabi; Andrew S Paulson; Mitesh J Borad; David Gallinson; Adrian G Murphy; Do-Youn Oh; Efrat Dotan; Daniel V Catenacci; Eric Van Cutsem; Tao Ji; Christine F Lihou; Huiling Zhen; Luis Féliz; Arndt Vogel
Journal:  Lancet Oncol       Date:  2020-03-20       Impact factor: 41.316

8.  Remdesivir for the Treatment of Covid-19 - Final Report.

Authors:  John H Beigel; Kay M Tomashek; Lori E Dodd; Aneesh K Mehta; Barry S Zingman; Andre C Kalil; Elizabeth Hohmann; Helen Y Chu; Annie Luetkemeyer; Susan Kline; Diego Lopez de Castilla; Robert W Finberg; Kerry Dierberg; Victor Tapson; Lanny Hsieh; Thomas F Patterson; Roger Paredes; Daniel A Sweeney; William R Short; Giota Touloumi; David Chien Lye; Norio Ohmagari; Myoung-Don Oh; Guillermo M Ruiz-Palacios; Thomas Benfield; Gerd Fätkenheuer; Mark G Kortepeter; Robert L Atmar; C Buddy Creech; Jens Lundgren; Abdel G Babiker; Sarah Pett; James D Neaton; Timothy H Burgess; Tyler Bonnett; Michelle Green; Mat Makowski; Anu Osinusi; Seema Nayak; H Clifford Lane
Journal:  N Engl J Med       Date:  2020-10-08       Impact factor: 91.245

9.  Prospective, historically controlled study to evaluate the efficacy and safety of a new paediatric formulation of nifurtimox in children aged 0 to 17 years with Chagas disease one year after treatment (CHICO).

Authors:  Jaime Altcheh; Luis Castro; Juan C Dib; Ulrike Grossmann; Erya Huang; Guillermo Moscatelli; Jimy José Pinto Rocha; Teresa Estela Ramírez
Journal:  PLoS Negl Trop Dis       Date:  2021-01-07

10.  Trends in FDA drug approvals over last 2 decades: An observational study.

Authors:  Angelika Batta; Bhupinder Singh Kalra; Raj Khirasaria
Journal:  J Family Med Prim Care       Date:  2020-01-28
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  2 in total

Review 1.  A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2021.

Authors:  Gizem Kayki-Mutlu; Zinnet Sevval Aksoyalp; Leszek Wojnowski; Martin C Michel
Journal:  Naunyn Schmiedebergs Arch Pharmacol       Date:  2022-05-11       Impact factor: 3.195

Review 2.  The Latest FDA-Approved Pharmaceuticals Containing Fragments of Tailor-Made Amino Acids and Fluorine.

Authors:  Qian Wang; Jianlin Han; Alexander Sorochinsky; Aitor Landa; Greg Butler; Vadim A Soloshonok
Journal:  Pharmaceuticals (Basel)       Date:  2022-08-14
  2 in total

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