© 2021 MJH Life Sciences™ and Patient Care Online. All rights reserved.
Associate Editor of Patient Care Online
Get a quick look at 14 of the many FDA-approved drugs in 2020 for conditions commonly seen in primary care.
The year 2020 has been one-of-a-kind as the novel coronavirus disease 2019 (COVID-19) began to spread globally just after the new year and "social distancing" has become everyday language.
Just like this unique year, there were a number of drugs approved by the US Food and Drug Administration (FDA) that were first-in-class or novel in another way in all 4 quarters of 2020. For example, the first and only FDA-approved COVID-19 treatment; the first adjuvanted, cell-based flu vaccine for use in persons aged ≥6 months; and a first-in-class adenosine triphosphate-citrate lyase inhibitor to treat heterozygous familial hypercholesterolemia. In the slides below, we recap these drugs and 11 more to prepare primary care clinicians for 2021.
Coronavirus disease 2019 (COVID-19): Veklury (remdesivir) Injection, is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (aged ≥12 years and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Remdesivir is the first and only approved COVID-19 treatment in the US and should only be administered in a hospital or health care setting. (Approved 10/22/20, Gilead Sciences Inc.)
For full prescribing information, please click here.
Influenza: Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) Injection, 0.5 mL, is the first adjuvanted, cell-based influenza vaccine to be FDA-approved for use in persons aged ≥6 months at increased risk of influenza A (H5NI). (Approved 1/31/20, Seqirus)
For full prescribing information, please click here.
Chronic Obstructive Pulmonary Disease (COPD): Breztri Aerosphere (budesonide 160 mcg/glycopyrrolate 9 mcg/formoterol fumarate 4.8 mcg) Metered Dose Inhalation, is a fixed dose triple-combination of budesonide, an inhaled corticosteroid; glycopyrrolate, an anticholinergic; and formoterol fumarate, a long-acting beta2-adrenergic agonist, indicated for the maintenance treatment of patients with COPD. (Approved 7/23/20, AstraZeneca)
For full prescribing information, please click here.
Type 2 Diabetes: Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Extended-Release Tablets, is a triple-combination tablet of empagliflozin, linagliptin, and metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. (Approved 1/27/20, Boehringer Ingelheim and Eli Lilly and Company)
For full prescribing information, please click here.
Diabetes: Semglee (insulin glargine) Injection, 100 units/mL, is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (Approved 6/11/20, Mylan N.V. and Biocon Ltd.)
For full prescribing information, please click here.
Diabetes: Lyumjev (insulin lispro-aabc) Injection, 100 units/mL and 200 units/mL, is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. (Approved 6/15/20, Eli Lilly and Company)
For full prescribing information, please click here.
Hypoglycemia: GvokeHypoPen™ (glucagon injection), is the first ready-to-use glucagon in a premixed autoinjector with no visible needle for the treatment of severe hypoglycemia in patients aged ≥2 years with diabetes. GvokeHypoPen is now available by prescription in the US. It is available in 2 doses with 0.5 mg/0.1 mL for children who weigh <100 lbs. and 1 mg/0.2 mL for children and adults who weight ≥100 lbs. (Approved in US 7/1/2020, Xeris Pharmaceuticals)
For full prescribing information, please click here.
Migraine: Nurtec ODT (rimegepant) Orally Disintegrating Tablets (ODT), 75 mg, the first and only calcitonin gene-related peptide receptor antagonist in fast-acting ODT form, is indicated for the acute treatment of migraine with or without aura in adults and is taken when needed. (Approved 2/27/20, Biohaven Pharmaceutical Holding Company Ltd.)
For full prescribing information, please click here.
Migraine: Vyepti (eptinezumab-jjmr) Injection, 100 mg/mL, is the first intravenous calcitonin gene-related peptide blocker for migraine prevention in adults with a recommended dosage of 100 mg every 3 months. (Approved 2/21/20, Lundbeck)
For full prescribing information, please click here.
Migraine: Elyxyb (celecoxib) Oral Solution, 25 mg/mL (formerly DFN-15), is a nonsteroidal anti-inflammatory drug indicated for the acute treatment of migraine with or without aura in adults with a recommended dose of 120 mg taken orally, with or without food. ELYXYB is not indicated for the preventive treatment of migraine. (Approved 5/5/20, Dr. Reddy’s Laboratories Limited)
For full prescribing information, please click here.
Heterozygous Familial Hypercholesterolemia (HeHF): Nexletol (bempedoic acid) Tablets, 180 mg, is a first-in-class, once daily, adenosine triphosphate-citrate lyase inhibitor indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeHF or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-cholesterol (LDL-C). (Approved 2/21/20, Esperion Therapeutics, Inc.)
For full prescribing information, please click here.
HeHF: Nexlizet (180 mg bempedoic acid and 10 mg ezetimibe) Tablets, is a once-daily combination of a first-in-class adenosine triphosphate-citrate lyase inhibitor and a cholesterol absorption inhibitor combination indicated as an adjunct to diet and maximally tolerated statin therapy for adults with HeHF or established ASCVD who require additional lowering of LDL-C. (Approved 2/26/20, Esperion Therapeutics)
For full prescribing information, please click here.
Pain: Qdolo (tramadol hydrochloride) Oral Solution, 5mg/mL, is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. (Approved 9/01/20, Athena Bioscience, LLC)
For full prescribing information, please click here.
Meningococcal Meningitis: MenQuadfi™️ (meningococcal (groups A, C, Y, W) conjugate vaccine) Injection, is indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in patients aged ≥2 years. It does not prevent N. meningitidis serogroup B disease. (Approved 4/23/20, Sanofi)
For full prescribing information, please click here.