Antiviral Drugs and Vaccine Take the Spotlight at Year's End
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n the final quarter of 2020, the FDA approved 13 new drugs and 7 new dosage forms. However, among those approvals were the first treatment for COVID-19 and emergency use authorization for two novel COVID-19 vaccines which may signal the COVID-19 pandemic is nearing its end and our lives may resume some degree of normalcy by the end of 2021.
Infectious Disease Treatment and Prevention:
Veklury (remdesivir), a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, became the first medication approved for the treatment of COVID-19 in October. PfizerBioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine, both novel mRNA vaccines, were issued emergency use authorization (EUA) for the prevention of COVID-19 in December. Inmazeb (atoltivimab/maftivimab/ odesivimab-ebgn), a combination of three recombinant human monoclonal antibodies, and Ebanga (ansuvimabzykl), a single IgG1 monoclonal antibody, became the first drugs approved for the treatment of Zaire ebolavirus, the virus that causes Ebola infection.
Chronic Care:
Imcivree (setmelanotide) is a melanocortin-4 receptor agonist which regulates appetite and fullness and increases resting metabolism approved for chronic weight management in obese patients whose obesity is due to certain genetic conditions including proopiomelanocortin (POMC) deficiency, proprotein subtilisin/ kexin type 1 (PCSK1) deficiency, or leptin receptor (LEPR) deficiency. Kesimpta (ofatumumab) is a CD20directed cytolytic antibody approved for relapsing forms of multiple sclerosis (MS). While not indicated for the treatment of an attack, Orladeyo (berotralstat), a plasma kallikrein inhibitor, was approved for the prevention of hereditary angioedema attacks. Oxlumo (lumasiran) is a small interfering ribonucleic acid (siRNA) for lowering urinary oxalate levels in patients with hyperoxaluria type 1. Zokinvy (lonafarnib) is a farnesytransferase inhibitor approved to treat rare conditions related to premature aging including Hutchinson-Gilford Progeria Syndrome. Gemtesa (vibegron), a beta-3 adrenergic agonist, treats overactive bladder symptoms including urgency, urge incontinence, and urinary frequency. Klisyri (tirbanibulin)
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is a microtubule inhibitor for topical treatment of actinic keratosis of the face or scalp.
Oncology:
Danyelza (naxitamab-gqgk) is a GD-2 binding monoclonal antibody approved for relapsing or refractory neuroblastoma in the bone or bone marrow in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). Orgovyx (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of advanced prostate cancer. Margenza (margetuximab) is a HER2/neu receptor antagonist approved to treat HER2+ breast cancer in combination with chemotherapy in patients with metastatic HER2+ breast cancer who have received two or more prior antiHER2 regimens.
Diagnostic Aids:
Gallium 68 PSMA-11 (Ga 68 PSMA-11) became the first drug approved for positron emission topography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
New Dosage Forms:
Several new dosage forms were approved including: Alkindi Sprinkle (hydrocortisone, oral granule sprinkle) for pediatric patients with adrenocortical insufficiency; Bronchitol (mannitol, powder for oral inhalation) as addon maintenance therapy to improve pulmonary function in adults with cystic fibrosis; Eysuvis (loteprednol, ophthalmic suspension) a short-term symptomatic treatment for dry eyes; Onureg (azacytidine, oral tablet) for acute myeloid leukemia; Qdolo (tramadol, oral solution) for pain; Thyquidity (levothyroxine, oral solution) for hypothyroidism and pituitary thyrotropin suppression; and Xaracoll (bupivacaine, implant) for postsurgical analgesia following open inguinal hernia repair. §
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