10 New Drugs for Primary Care: Q3 2019
The third quarter saw several novel drugs win FDA-approval for a variety of conditions often seen in primary care.
Another quarter has ended, which means Patient Care® Online has compiled another list of new FDA-approved drugs for primary care and they surely did not disappoint. Numerous "firsts" were approved for various conditions ranging from asthma to type 2 diabetes to pneumonia.
Click through the slideshow below to get details on the first and only glucagon-like peptide-1 analog in pill form; the first ready-to-use injection for hypoglycemia; the first digital inhaler for asthma that connects to a mobile app; and more.
Hypertension/Coronary Artery Disease: Katerzia (amlodipine benzoate) Oral Suspension, 1 mg/mL, the first and only FDA-approved amlodipine oral suspension indicated for the treatment of hypertension in adults and pediatric patients aged ≥6 years, and coronary artery disease in adults. (Approved 7/8/19, Silvergate Pharmaceuticals, Inc.)
For full prescribing information, please click here.
Asthma: AirDuo® Digihaler™ (fluticasone propionate 113 µcg and salmeterol 14 µcg) Inhalation Powder, the first digital maintenance inhaler that has built-in sensors that connect to a mobile app via Bluetooth® to record and store information on inhaler use. It combines a breath-actuated, multi-dose dry powder inhaler with an inhaled corticosteroid (fluticasone propionate) and a long-acting beta2-adrenergic-agonist (salmeterol) to treat asthma in patients aged ≥12 years. (Approved 7/15/19, Teva Pharmaceuticals Inc.)
For full prescribing information, please click here.
Urinary Tract Infection, Intra-abdominal Infection: Recarbrio (imipenem, cilastatin, and relebactam), 1.25g, combines imipenem-cilastatin (an antibiotic) and relebactam (a new β-lactamase inhibitor) for injection in patients aged ≥18 years with complicated urinary tract infections and complicated intra-abdominal infections. (Approved 7/16/19, Merck)
For full prescribing information, please click here.
Inflammatory Diseases: Hadlima (adalimumab-bwwd) Injection, biosimilar to Humira (adalimumab), a tumor necrosis factor blocker approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis. (Approved 7/23/19, Samsung Bioepis Co., Ltd.)
For full prescribing information, please click here.
Hypoglycemia: Baqsimi (glucagon) Nasal Powder, 3mg, the first noninjectable glucagon therapy approved for the emergency treatment of severe hypoglycemia that is administered with a single-use dry powder dispenser. Baqsimi is indicated for patients with diabetes aged ≥4 years. (Approved 7/24/19, Eli Lilly and Company)
For full prescribing information, please click here.
Rheumatoid Arthritis: Rinvoq (upadacitinib) Extended-Release Tablets, 15 mg, a once-daily oral Janus kinase inhibitor for the treatment of moderate-to-severe rheumatoid arthritis in adults who have had either an inadequate response or intolerance to methotrexate. (Approved 8/16/19, AbbVie Inc.)
For full prescribing information, please click here.
Pneumonia: Xenleta (lefamulin) Tablets and Injection, a first-in-class, semi-synthetic pleuromutilin antibiotic that can be administered either orally (600mg) or intravenously (150mg) every 12 hours to treat adults with community-acquired bacterial pneumonia. It is the first intravenous and oral antibiotic with a novel mechanism of action to be approved in nearly 20 years. (Approved 8/19/19, Nabriva Therapeutics plc)
For full prescribing information, please click here.
Hypoglycemia: Gvoke (glucagon) Ready-to-Use Injection, the first FDA-approved premade stable liquid glucagon to quickly treat severe hypoglycemia in patients with diabetes aged ≥2 years; available in 0.5mg/0.1mL for pediatric patients and 1mg/0.2mL for adolescent and adult patients. (Approved 9/10/19, Xeris Pharmaceuticals, Inc.)
For full prescribing information, please click here.
Irritable Bowel Syndrome-C: Ibsrela (tenapanor) Tablets, 50mg, a first-in-class, sodium/hydrogen exchanger 3 inhibitor taken twice a day for the treatment of irritable bowel syndrome with constipation in adults. (Approved 9/12/19, Ardelyx, Inc)
For full prescribing information, please click here.
Type 2 Diabetes Mellitus (T2DM): Rybelsus (semaglutide) Tablets, the first and only glucagon-like peptide-1 analog in pill form indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM who are not responding to current treatment; available in 7mg or 14mg tablets. (Approved 9/20/19, Novo Nordisk)
For full prescribing information, please click here.
For a quick review of primary care drugs approved in the first quarter of 2019, please go to 10 New Drugs for Primary Care: Q1 2019.
For a quick review of primary care drugs approved in the second quarter of 2019, please go to 7 New Drugs for Primary Care: Q2 2019.