12 Drugs Approved for Primary Care in 2021
With 2021 nearing an end, Patient Care Online has compiled a list of key drugs approved this year by the US Food and Drug Administration for conditions that are often seen in primary care. Scroll through the slides below to find details on the novel COVID-19 vaccine, a novel agent for the treatment of heart failure, the first and only antihistamine nasal spray for allergies available over-the-counter, and 9 more.
Heart Failure with Reduced Ejection Fraction (HFrEF): Verquvo (vericiguat) Tablets, 2.5 mg, 5 mg, 10 mg
A novel soluble guanylate cyclase stimulator indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following hospitalization for heart failure or need for outpatient intravenous (IV) diuretics in adults with symptomatic chronic HF and left ventricular ejection fraction <45%. Vericiguat is the first treatment approved specifically for this HF patient population. (Approved 1/19/21, Merck) Please click here for full prescribing information.
Hypoglycemia: Zegalogue (dasiglucagon) Injection, 0.6 mg/0.6 mL
An antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged ≥6 years. It is available as a single-dose autoinjector and a single-dose prefilled syringe. (Approved 3/22/21, Zealand Pharma A/S) Please click here for full prescribing information.
Pregnancy Prevention: Nextstellis (drospirenone and estetrol [E4]) Tablets
A novel oral contraceptive pill containing 3 mg drospirenone (a progestin) and 14.2 mg estetrol, indicated for use by women of reproductive potential to prevent pregnancy. Estetrol is an estrogen naturally produced during pregnancy that can now be made from a plant source. (Approved 4/15/2021, Mayne Pharma) Please click here for full prescribing information.
Opioid Overdose: Kloxxado (naloxone hydrochloride) Nasal Spray, 8 mg
An opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. It is not a substitute for emergency medical care. (Approved 4/30/21, Hikma Pharmaceuticals PLC) Please click here for full prescribing information.
Allergic Rhinitis: Astepro Allergy (azelastine hydrochloride nasal spray, 0.15%)
The first and only steroid-free, antihistamine nasal spray for allergies available over-the-counter in the US. It is indicated for the temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to allergic rhinitis or other upper respiratory allergies for adults and children aged ≥6 years. (Approved 6/17/21, Bayer Healthcare LLC) Please click here for the product label.
Obesity: Wegovy (semaglutide 2.4 mg) Injection
The first once-weekly glucagon-like peptide-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI≥30 kg/m2) or overweight (BMI≥27 kg/m2) with at least 1 weight-related comorbidity (eg, hypertension, hyperlipidemia, type 2 diabetes). (Approved 6/4/21, Novo Nordisk) Please click here for full prescribing information.
Pneumococcal Disease: Prevnar 20 (pneumococcal 20-valent conjugate vaccine) Injection
The first conjugate vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults aged ≥18 years. (Approved 6/8/21, Pfizer. 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.
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 10 mg or 20 mg orally once daily based on eGFR and serum potassium thresholds. (Approved 7/09/21, Bayer Healthcare) 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.
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.
