8 New Drugs Approved for Primary Care: Q4 2021
The fourth quarter has come and gone, which means Patient Care Online has compiled another list of drugs approved by the US Food and Drug Administration for conditions that are often seen in primary care. In the slides below, find details on the first and only biologic that specifically binds to and inhibits the IL-13 cytokine approved for the treatment of atopic dermatitis, a first-in-class small interfering RNA to reduce low-density lipoprotein cholesterol, the first injectable pre-exposure prevention treatment for HIV-1 infection, and 5 more.
Opioid Overdose: Zimhi (naloxone hydrochloride) Injection, 5 mg/0.5 mL
An opioid antagonist indicated in adult and pediatric patients for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. (Approved 10/15/2021, Adamis Pharmaceutics Corporation) Please click here for full prescribing information.
Pain: Seglentis (celecoxib and tramadol hydrochloride) Tablets
A nonsteroidal anti-inflammatory drug and opioid agonist combination indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. (Approved 10/15/2021, Esteve Pharmaceuticals, S.A.) Please click here for full prescribing information.
Epilepsy/Migraine Prevention: Eprontia (topiramate) Oral Solution, 25 mg/mL
A ready-to-use liquid formulation of the approved anticonvulsant topiramate for use as initial monotherapy in the treatment of partial-onset or primary generalized tonic-clonic seizures in patients aged ≥2 years and as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients aged ≥2 years. It is also approved for the preventive treatment of migraine in patients aged ≥12 years. (Approved 11/05/2021, Azurity Pharmaceuticals, Inc.) Please click here for full prescribing information.
Asthma: Tezspire (tezepelumab-ekko) Injection, 210 mg/1.91 mL, (110 mg/mL)
A thymic stromal lymphopoietin blocker, human monoclonal antibody, indicated for the add-on maintenance treatment of adult and pediatric patients aged ≥12 years with severe asthma. (Approved 12/17/2021, Amgen and AstraZeneca) Please click here for full prescribing information.
Inflammatory Diseases: Yusimry (adalimumab-aqvh) Injection, 40 mg
A tumor necrosis factor blocker biosimilar to Humira (adalimumab), approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis. (Approved 12/17/2021, CoherusBioSciences, Inc.) Please click here for full prescribing information.
HIV: Apretude (cabotegravir) Extended-Release Injectable Suspension, 600 mg/3 mL (200 mg/mL)
A long-acting injectable integrase strand transfer inhibitor indicated for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg. (Approved 12/20/21, ViiV Healthcare) Please click here for full prescribing information.
Heterozygous Familial Hypercholesterolemia (HeFH): Leqvio (inclisiran) Injection
A small interfering RNA directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol. (Approved 12/22/2021, Novartis) Please click here for full prescribing information.
Atopic Dermatitis: Adbry (tralokinumab-ldrm) Injection, 150 mg/mL
A novel interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It can be used with or without topical corticosteroids. (Approved 12/27/21, LEO Pharma Inc.) Please click here for full prescribing information.
For more information on FDA-approved medications from 2021, check out 12 Drugs Approved for Primary Care in 2021
