FDA approves 139 NDA/BLA applications for near-historic number of innovative drugs...

Forest 2020 is coming to an end, a year in which the FDA has not been affected by the development and approval of new drugs, and the number of new drugs approved by the FDA in 2020 remains high, despite the global epidemic of new crown pneumonia.
139 NDA/BLA applications were approved by the FDA as of December 24, including 53 innovative drugs, second only to the record 59 in 2018.
2020, the FDA approved 139 NDA/BLA applications, including 21 BLA and 118 NDA, according to FDA-approved new drug analysis data.
BLA applications approved can be found in the article "2020 Inventory" FDA approves 21 BLA applications, and several heavy-duty targeted drugs are approved for market! The 118 approved NDA applications included 40 new molecular entities (43 application numbers), 27 new dosage forms, 23 new formulations and, unlike others, 8 new drug combinations.
1: In 2020, the FDA approved the NDA's application for submission classification (source: Pharmaceutical Intelligence U.S. Listed Drugs Database) 22 of the 40 new molecular entities approved by the NDA this year, more than half of the total number approved.
after rare disease therapies overcame cancer drugs in 2018 and 2019 to become the largest number of new drugs approved, this year's rare disease treatments far outsized other types of drugs.
in the approved enterprises, biologics declaration to large pharmaceutical companies, and small research and development enterprises to declare new molecular physical drugs momentum.
2020 FDA-approved new molecular entity statistics data show that as of December 24, the FDA approved the number of new class 1 drug NDA application number 43, involving 40 new molecular entities.
: 2020 FDA Approval of New Molecular Entities Note: Data as of 2020.12.24, data manually collated by the author, there may be some omissions and errors.
1, gemtesaGemtesa (vibegron) is a daily oral beta-3 epinephrine-based atrial astrologist developed by Urovant Sciences to treat adult patients with bladder hyperactive disorder (OAB) accompanied by acute urinary incontinence (UUI), urinary uremia, and urinary frequency symptoms.
studies have shown that the drug selectively activates beta-3 epinephrine-energy ligands, the most common β epinephrine-energy-to-the-body in bladder smooth muscles, thus stretching smooth muscles and increasing bladder capacity, thereby reducing OAB symptoms.
this approval is the first innovative oral prescription drug approved by the FDA to treat such patients since 2012.
2, ORGOVYXOrgovyx (relugolix) is an oral GnRH-subject antagonist developed by Myovant Sciences to treat adult patients with advanced prostate cancer.
the drug is the first and only oral gonogen-releasing hormone (GnRH) regulatory antagonist approved by the FDA for the treatment of advanced prostate cancer.
in addition to developing oral relugolix tablets to treat advanced prostate cancer, Myovant Sciences is also developing relugolix compound tablets (relugolix 40mg, estradiol 1.0mg, acetaminophen 0.5mg) to treat uterine fibroids and endometriosis in women.
3, KLISYRI Klisyri (tirbanibulin) is a micro-tube inhibitor developed by Atenex and Almirall for the local treatment of photochemic keracial disease (actinic keratosis, AK).
Klisyri will be produced by Atenex and will be launched jointly with Almirall in the United States in the first quarter of 2021.
4, ORLADEYOOrladeyo (Berotralstat) is a new, oral, 1 daily, powerful, selective human plasma peptide release enzyme inhibitor developed by BioCryst to prevent hereditary angioedema (HAE) attacks in children and adults 12 years of age and older.
Orladeyo is the first oral nonsteroidal drug to prevent HAE seizures.
HAE is a rare genetic disorder that affects an estimated 2-10 people worldwide for every 100,000 people.
5, GALLIUM GA 68 PSMA-11 PSMA-11 (Ga 68 PSMA-11) was jointly developed by UCLA and the University of San Francisco for patients suspected of prostate cancer metastasis and may be cured by surgery or radiation therapy.
is the first drug approved for positive PSMA-positive lesions in male prostate cancer patients.
the drug is also intended for patients who suspect a recurrence of prostate cancer based on elevated levels of serum prostate-specific antigens (PSA).
6, IMCIVREEImcivride (Setmelanotide) is Rhythm's development of a melanocortin-4 receptor (melanocortin-4 receptor, MC4R) exciter for chronic weight management in obese children and adults 6 years of age and older.
Imcivree was the first FDA-approved treatment for these rare genetic obesity.
must pass genetic testing to confirm that variants of the poMC, PCSK1, or LEPR genes are interpreted as pathogenic, possibly pathogenic or uncertain (VUS).
7, OXLUMO Oxlumo (lumasiran) is a targeted hydroxygen oxidase 1 (HAO1) mRNA RNAi therapy developed by Allenlam to treat primary high oxalic aciduria (PH1) in all age groups.
Oxlumo is the first drug approved for PH1 and the only treatment to be shown to lower harmful oxalic acid levels.
the United States, Oxlumo has been awarded the FDA's pediatric rare disease qualification for PH1 treatment, orphan drug qualification, breakthrough drug qualification.
in the European Union, Oxlumo has been granted the orphan drug qualification, priority drug qualification.
it's worth noting that, in addition to approving Oxlumo, the FDA awarded Allenylam a Rare Pediatric Disease Priority Review Certificate (PRV) to reward the company for its outstanding contribution to the development of new drugs for rare pediatric diseases.
8, ZOKINVYZokinvy (Lonafarnib) is a frenchiki transferase inhibitor (FTI) used to treat early aging (HGPS) and premature aging-like nuclear fiber layer protein disease (PL).
the drug is the world's first approved treatment for early aging, has been treated with early aging priority review qualification, orphan drug qualification, breakthrough therapy.
treatment research is funded primarily by the Progeria Research Foundation in Massachusetts and is supported by drug developer Eiger BioPharmaceutical.
9, VEKLURYVEKLURY (remdesivir, Redsivir) is an antiviral drug produced by Gilead Sciences for new coronary pneumonia patients over the age of 12 who require hospitalization, after Redsyvir was granted an FDA Emergency Use Authorization (EUA).
the first approved new coronary pneumonia treatment in the United States, but the drug has been controversial, with the World Health Organization declaring that Redsyvir is "almost ineffective" in reducing the death rate from new coronary pneumonia.
10, GAVRETOGavreto (pralsetinib) is a once-a-day oral RET targeted therapy developed by Blueprint Medicines, which has been approved by the FDA for the treatment of adult patients with metastasis non-small cell lung cancer (NSCLC) that has been confirmed as RET fusion positive by FDA-approved testing methods.
December, the FDA accelerated approval of Gawreto's extended adaptation for the treatment of advanced or metastatic transfective refly gene (RET) mutant thyroid myelin cancer (MTC) in children and adults 12 years and older who require systemic treatment and radioactive iodine incurable late stage or metastatic RET fusion positive MTC.
is the second RET inhibitor approved for listing in the world.
11, DETECTNETDetectnet (Cu 64 DOTATATE) is a radiodiagnostic reagent developed jointly by RadioMedix and Curium for the use of positive neuroendocrine tumors (NETs) in adults using positive electron emission fault scanning (PET).
Detectnet is the first diagnostic reagent to connect Cu 64 radioisotopes with the growth inhibitor-like DOTATATE.
12, WINLEVI Winlevi (clascoterone) is a "first- and foreboding" exome hormone-inhibitor developed by Cassiopea for the treatment of common acne in people over 12 years of age.
is the first AC drug approved by the FDA in 40 years with an innovative mechanism.
13, VILTEPSOViltepso is an antonymable oligonucleotide (ASO) therapy developed by NS Pharma, a subsidiary of Nippon Shinyaku, japan, for the treatment of patients with dystrophy (DMD) in exon 53 exon 53 skipping.
Viltepso was the first and only exon to be shown to increase antimyostrophy protein levels in children as young as 4 years of age.
14, EVRYSDIevrysdi (risdiplam) was developed by Roche's Geneneck to treat patients with spinal muscular dystrophy (SMA) in children 2 months and older.
Evrysdi is a motor neuron survival gene 2 (SMN2) mRNA shear modifier, the first oral treatment for SMA and the first SMA therapy to be given at home.
is expected to become the third heavyweight bomb in the SMA field, after Spinraza and Zolgensma.
15, OLINVYK Olinvyk (oliceridine) is an opioid agonist developed by Trevena to treat moderate to severe acute pain in adults, specifically in patients who need intravenous opioids, alternative therapies, and inadequate pain control.
Oliceridine is a new generation of opioids that selectively agitate G proteins on μ-subjects and have less effect on β-arrestin, reducing the occurrence of associated adverse reactions.
16, LAMPITLampit (nifurtimox, nitromos) is Bayer's, a new, semotic, dispersable tablet that can be dipped by hand at the marker line.
used in pediatric patients (under 0 to 18 years of age, weight ≥2.5 kg) to treat Chagas disease (a.k.a., South American trypanosomiasis) caused by T. cruzi.
the World Health Organization estimates that 8 million people worldwide are infected with the Chagas disease pathogen, a more common disease in South America.
chagas disease is likened to the new "AIDS", in addition to this product, only benznidazole has been approved for Chagas disease.
17, XEGLYZE Xeglyze (Abametapir) is India Dr. A metalloproteinase inhibitor developed by Reddy's for the local treatment of head lice infection in patients 6 months and older.
Xeglyze contains benzoyl alcohol, and systemic exposure to benzoyl alcohol in some patients is prone to serious and fatal adverse reactions, including "breathing syndrome" in newborns and low-birth-weight infants.
Xeglyze has not been determined in children under 6 months of age.
Despite the widespread use of pesticides, head lice infections are still widespread in modern society, especially among children, and although the FDA has approved multiple drugs, abametapir will be a better choice for people with drug-resistant lice.
18, INQOVIInqovi (cedazuridine/decitabine, dixitabine) is an oral fixed-dose combination anticancer drug developed by Astex, a pharmaceutical subsidiary of Otsuka, for the treatment of adult patients with bone marrow growth syndrome (MDS) and chronic myeloid monocyte leukemia (CMML).
Inqovi is the first oral low methylation preparation approved for the treatment of MDS and CMML in the United States.
FDA granted Inqovi eligibility and priority examination of orphan drugs for the treatment of MDS and CMML.
approval is a significant advance in treatment options for MDS patients.
19, BYFAVO Byfavo (Remimazolam) is an ultra-short-acting benzodiazepine drug developed by Acacia for sedative induction or maintenance in adult surgery that lasts no more than 30 minutes.
the drug is a GABA agitant that acts on GABA subjects, especially GABA-alpha.
Remimazolam combines the properties of two anaesthetic drugs, Midazolam (Midazolam, which acts on GABA subjects) and remifentanil (refentanil, organ independent metabolism).
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