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Drug Approvals 2021

Drug Approvals 2021

Published on 13-Sept-2021

In 2021, the FDA has approved many novel products that serve previously unmet medical needs or significantly help to advance patient quality of life. The broad indication wise distribution of all CDER’s 2021 drug approvals indicates notable advances in drug discovery1,2.

New Drug Approvals & Drugs in Pipeline (FDA) for 2021*

Table 1. Approved Drug List
Table 2. Drugs in Pipeline

*This information is updated as July 31, 2021; listed alphabetically by trade name.

Significant drug launches of 2021

  • Verquvo (Vericiguat, MERCK SHARP DOHME, 01/19/2021)
    Mitigates the risk of cardiovascular death and hospitalization for chronic heart failure 
  • Cabenuva (Cabotegravir and Rilpivirine (Co-Packaged), VIIV HLTHCARE, 01/21/2021)
    Treats HIV 
  • Lupkynis (Voclosporin, AURINIA, 01/22/2021)
    Treats lupus nephritis 
  • Tepmetko (Tepotinib, EMD SERONO INC, 02/03/2021)
    Treats non-small cell lung cancer 
  • Ukoniq (Umbralisib Tosylate, TG THERAPS, 02/05/2021) 
    Treats marginal zone lymphoma and follicular lymphoma 
  • Evkeeza (Evinacumab-Dgnb, REGENERON PHARMACEUTICALS, 02/11/2021) 
    Treats homozygous familial hypercholesterolemia
  • Cosela (Trilacicilib Dihydrochloride, G1 THERAP, 02/12/2021), 
    Mitigates chemotherapy-induced myelosuppression in small cell lung cancer
  • Amondys 45 (Casimersen, SAREPTA THERAPS INC, 02/25/2021)
    Treats Duchenne muscular dystrophy
  • Nulibry (Fosdenopterin Hydrobromide, ORIGIN, 02/26/2021) 
    Reduces the risk of mortality in molybdenum cofactor deficiency Type A 
  • Pepaxto (Melphalan Flufenamide Hydrochloride, ONCOPEPTIDES AB, 02/26/2021)
    Treats relapsed or refractory multiple myeloma 
  • Azstarys (Serdexmethylphenidate Hydrochloride; Dexmethylphenidate Chloride, COMMAVE THERAP, 03/02/2021)
    Treats attention deficit hyperactivity disorder 
  • Fotivda (Tivozanib Hydrochloride, AVEO PHARMS, 03/10/2021)
    Treats renal cell carcinoma 
  • Ponvory (Ponesimod, JANSSEN PHARMS, 03/18/2021)
    Treats relapsing forms of multiple sclerosis
  • Zegalogue (Dasiglucagon Hydrochloride, ZEALAND PHARMA, 03/22/2021)
    Treats severe hypoglycemia 
  • Qelbree (Viloxazine Hydrochloride, SUPERNUS PHARMS, 04/02/2021)
    Treats attention deficit hyperactivity disorder 
  • Nextstellis (Drospirenone; Estetrol, MAYNE PHARMA, 04/15/2021)
    Prevents pregnancy 
  • Jemperli (Dostarlimab-Gxly, GLAXOSMITHKLINE, 04/22/2021)
    Treats endometrial cancer 
  • Zynlonta (Loncastuximab Tesirine-Lpyl, ADC Therapeutics SA, 04/23/2021)
    Treats certain types of relapsed or refractory large B-cell lymphoma 
  • Empaveli (Pegcetacoplan, APELLIS PHARMS, 05/14/2021)
    Treats paroxysmal nocturnal hemoglobinuria 
  • Rybrevant (Amivantamab-Vmjw, JANSSEN BIOTECH, 05/21/2021)
    Treats a subset of non-small cell lung cancer 
  • Pylarify (Piflufolastat F-18, PROGENICS PHARMS INC, 05/26/2021)
    Identifies prostate-specific membrane antigen-positive lesions in prostate cancer 
  • Lumakras (Sotorasib SIB, AMGEN INC, 05/28/2021)
    Treats types of non-small cell lung cancer 
  • Truseltiq (Infigratinib Phosphate, QED THERAP, 05/28/2021)
    Treats cholangiocarcinoma whose disease meets certain criteria
  • Lybalvi (Olanzapine; Samidorphan L-Malate, ALKERMES INC, 05/28/2021)
    Treats schizophrenia and certain aspects of bipolar I disorder
  • Brexafemme (Ibrexafungerp Citrate, SCYNEXIS, 06/01/2021)
    Treats vulvovaginal candidiasis
  • Aduhelm (Aducanumab-Avwa, BIOGEN INC, 06/07/2021)
    Treats Alzheimer’s disease 
  • Rylaze (Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn, JAZZ PHARMS, 06/30/2021)
    Treats acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen 
  • Kerendia (Finerenone, BAYER HEALTHCARE PHARMACEUTICALS INC, 07/09/2021)
    Reduces the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes 
  • Fexinidazole (Fexinidazole, DNDI, 07/16/2021)
    Treats human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense 
  • Rezurock (Belumosudil, KADMON PHARMS LLC, 07/16/2021)
    Treats chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy
  • Bylvay (Odevixibat, ALBIREO PHARMA INC, 07/20/2021)
    Treats pruritus 
  • Twyneo (Tretinoin and benzoyl peroxide, SOL-GEL TECHNOLOGIES LTD, 07/26/2021)
    It is a topical retinoid and antibacterial fixed-dose combination for the treatment of acne vulgaris in adults and children 9 years of age and older
  • Saphnelo (Anifrolumab, AstraZeneca, 07/30/2021)
    It is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy 

Significant Drug launches in Pipeline for 2021

  • Oteseconazole (VT-1161, MYCOVIA PHARMACEUTICALS INC)
    It is an investigational oral antifungal in development for the treatment of recurrent vulvovaginal candidiasis (RVVC)
  • Sulopenem (ITERUM THERAPEUTICS PLC)
    It is an orally bioavailable, broad-spectrum penem β-lactam antibiotic in development for the treatment of infections caused by multi-drug resistant bacteria
  • Brixadi (Buprenorphine, BRAEBURN INC)
    It is a long-acting partial opioid agonist injection formulation in development for the treatment of opioid use disorder
  • Tenapanor (ARDELYX INC)
    It is a sodium/hydrogen exchanger 3 (NHE3) inhibitor in development for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis or Hyperphosphatemia of Renal Failure
  • Libervant (Diazepam, AQUESTIVE THERAPEUTICS INC)
    It is a buccal film formulation of the approved benzodiazepine diazepam in development for the management of seizure clusters
  • Roxadustat (FG-4592, FIBROGEN INC)
    It is a first-in-class, orally administered small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor in development for the treatment of anaemia of chronic kidney disease (CKD)
  • Tezepelumab (AMGEN AND ASTRAZENECA)
    It is an investigational, potential first-in-class anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody in development for the treatment of severe asthma
  • LV-101 (Carbetocin intranasal, LEVO THERAPEUTICS INC)
    It is an oxytocin analog in development as a treatment for hyperphagia and behavioral distress associated with Prader-Willi syndrome (PWS)
  • Teplizumab (PROVENTION BIO INC)
    It is an investigational anti-CD3 monoclonal antibody (mAb) in development for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals
  • Surufatinib (HUTCHISON CHINA MEDITECH LIMITED)
    It is a novel, oral angio-immuno kinase inhibitor in development for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (“NET”)
  • Lenacapavir (GILEAD SCIENCES INC)
    It is an investigational, long-acting HIV-1 capsid inhibitor in development for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection
  • Vutrisiran (ALNYLAM PHARMACEUTICALS INC)
    It is an investigational RNAi therapeutic in development for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults
  • Pedmark (Sodium thiosulfate, FENNEC PHARMACEUTICALS INC)
    It is a cisplatin neutralizing agent in development for the protection against hearing loss in pediatric patients receiving cisplatin chemotherapy
  • Mitapivat (AGIOS PHARMACEUTICALS, INC)
    It is a protein kinase-R (PKR) activator in development for the treatment of adults with pyruvate kinase (PK) deficiency
  • Arimoclomol (ORPHAZYME A/S)
    It is an investigational Heat-Shock Protein amplifier in development for the treatment of Niemann-Pick disease Type C (NPC)
  • Ruxolitinib (INCYTE DERMATOLOGY)
    It is a JAK1/JAK2 inhibitor formulated for topical application in development for the treatment of atopic dermatitis and vitiligo
  • Zimhi (Naloxone hydrochloride, ADAMIS PHARMACEUTICALS CORPORATION)
    It is a high-dose formulation of the approved opioid antagonist naloxone in development for the treatment of opioid overdose
  • Tapinarof (DERMAVANT SCIENCES)
    It is a topical aryl hydrocarbon receptor (AhR) modulating agent in development for the treatment of plaque psoriasis and atopic dermatitis
  • Plinabulin (BEYONDSPRING INC)
    It is a selective immunomodulating microtubule-binding agent (SIMBA) in development for use in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN)

References

  1. US FDA
  2. Drugs.com

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