8 New Drugs Approved for Primary Care: Q3 2021
The third 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 novel COVID-19 vaccine, a novel topical agent for atopic dermatitis, and 6 more.
Chronic Kidney Disease (CKD) Associated with Type 2 Diabetes (T2D): Kerendia (finerenone) Tablets
A first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) is indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D. The recommended starting dosage is 10mg or 20mg orally once daily based on eGFR and serum potassium thresholds. (Approved 7/09/21, Bayer Healthcare) Please click here for full prescribing information.
Pneumococcal Disease: Vaxneuvance™ (Pneumococcal 15-valent Conjugate Vaccine) Suspension for Intramuscular Injection, 0.5mL
Is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults aged ≥18 years. (Approved 7/16/21, Merck) Please click here for full prescribing information.
Acne: Twyneo (0.1% tretinoin and 3% benzoyl peroxide) Cream
Is a combination of tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients aged ≥9 years. (Approved 7/26/21, Sol-Gel Technologies, Ltd.) Please click here for full prescribing information.
Systemic Lupus Erythematosus (SLE): Saphnelo™(anifrolumab-fnia) Injection
A first-in-class type I interferon receptor antagonist for the treatment of adults with moderate-to-severe SLE who are receiving standard therapy. It is the first new treatment for generalized SLE to receive approval in over a decade. The recommended dosage is 300mg as an intravenous infusion over a 30-minute period every 4 weeks. Anifrolumab is not recommended for patients with severe active lupus nephritis or severe active central nervous system lupus as the efficacy of anifrolumab has not been evaluated. (Approved 7/30/21, AstraZeneca) Please click here for full prescribing information.
Migraine: Qulipta (atogepant) Tablets
A calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of episodic migraine in adults. The recommended dosage is 10mg, 30mg, or 60mg taken orally once daily with or without food. (Approved 9/28/21, AbbVie Inc.) Please click here for full prescribing information.
COVID-19: Comirnaty (COVID-19 Vaccine, mRNA) Injection
Is the first vaccine to receive approval for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in persons aged ≥16 years. It is administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart. For certain populations, the vaccine remains available under US FDA emergency use authorization: for persons aged 12 to 15 years and for the administration of a third dose in certain immunocompromised patients. (Approved 8/23/21, Pfizer Inc. and BioNTech SE) Please click here for full prescribing information.
Migraine: Trudhesa (dihydroergotamine mesylate) Nasal Spray, (formerly INP104)
Is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. This migraine therapeutic is delivered in a dose of 0.725mg into each nostril. It is not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine. (Approved 9/2/21, Impel Neuropharma) Please click here for full prescribing information.
Atopic Dermatitis: Opzelura (ruxolitinib) Cream
Is the first and only topical formulation of a Janus kinase (JAK) inhibitor to receive approval in the US. It is indicated for the short-term and noncontinuous chronic treatment of mild-to-moderate atopic dermatitis in nonimmunocompromised patients aged ≥12 years whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. (Approved 9/21/21, Incyte Corp) Please click here for full prescribing information.
For more information on FDA-approved medications from 2021, check out 6 New Drugs Approved for Primary Care: Q1 2021 and 6 New Drugs Approved for Primary Care: Q2 2021.
