At the close of the first quarter of a new decade, Patient Care® Online has compiled a list of 9 new FDA-approved drugs for conditions that are often seen in primary care. Scroll through the slides below to find details on the first intravenous calcitonin gene-related peptide blocker for migraine prevention; the first and only oral immunotherapy for peanut allergies; a first-in-class collection method that utilizes saliva as the primary test biomaterial for COVID-19; and 6 more.
Coronavirus disease 2019 (COVID-19): The FDA granted emergency use authorization to Rutgers University for a first-in-class collection method that utilizes saliva as the primary test biomaterial for COVID-19 and can be self-administered to help protect health care workers against infection. (Approved 4/13/20, RUCDR Infinite Biologics)
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.
Peanut Allergy: Palforzia (Peanut [Arachis hypogaea)] Allergen Powder-dnfp) (formerly AR101), is the first and only oral immunotherapy to be FDA-approved to reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts in patients aged 4-17 years who have a confirmed diagnosis of peanut allergy. (Approved 1/31/20, Aimmune Therapeutics, 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.
Pain: Anjeso (meloxicam) Injection, 30 mg, is a once-daily nonsteroidal anti-inflammatory drug (NSAID) that received approval for the management of moderate-to-severe pain in adults, alone or in combination with other non-NSAID analgesics. It is administered by intravenous bolus injection over 15 seconds. (Approved 2/20/20, Baudax Bio, Inc.)
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, 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.
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: 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.
For a quick review of primary care drugs approved in the fourth quarter of 2019, check out 10 New Drugs for Primary Care: Q4 2019.
For a quick review of primary care drugs approved in the third quarter of 2019, check out 10 New Drugs for Primary Care: Q3 2019.
For a quick review of primary care drugs approved in the second quarter of 2019, check out 7 New Drugs for Primary Care: Q2 2019.
For a quick review of primary care drugs approved in the first quarter of 2019, check out 10 New Drugs for Primary Care: Q1 2019.
