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Endocrinology drug approvals from 2017
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In a review of the 2017 milestones, Endocrine Today compiled a list of drugs related to the field that were newly approved, cleared and had label or indication changes. We put our best effort into making a complete list and regret any omission.
Appearance of a drug does not constitute any endorsement by Endocrine Today, its editors, publishers or editorial board.
Parsabiv (etelcalcetide) — February
The FDA recently approved etelcalcetide for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, according to a release from Amgen.
Etelcalcetide (Parsabiv) can be administered to patients by their dialysis health care team three times per week at the end of their hemodialysis session. Read more.
Qtern (dapagliflozin/saxagliptin) — February
The FDA has approved a once-daily combination of the SGLT2 inhibitor dapagliflozin and the DPP-IV inhibitor saxagliptin for the treatment of type 2 diabetes, AstraZeneca announced in a press release.
The combination therapy (Qtern), is intended for patients with type 2 diabetes inadequately controlled with dapagliflozin (Farxiga; 10 mg) or who are already treated with both dapagliflozin and saxagliptin (Onglyza) therapy. The drug is indicated as an adjunct to diet and exercise. Read more.
Trulicity (dulaglutide) — February
The FDA has approved a label update for the GLP-1 receptor agonist dulaglutide, allowing for its use in combination with basal insulin for adults with type 2 diabetes, Eli Lilly announced in a press release.
The update makes dulaglutide (Trulicity), the first GLP-1 receptor agonist with a label indication for combination use with mealtime insulin or basal insulin. Read more.
Tymlos (abaloparatide) — April
The FDA today approved an abaloparatide injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture, according to a press release from Radius Health.
The approval of abaloparatide (Tymlos, Radius Health) is based on results from the 18-month ACTIVE trial and the first 6 months of the ACTIVExtend trial which resulted in consistent significant reduction in the risk for vertebral fractures regardless of age, years since menopause, presence or absence of prior fracture and bone mineral density at baseline. Compared with placebo, abaloparatide reduced the risk for new vertebral fractures by 86% and the risk for nonvertebral fractures by 43%. Read more.
Triptorelin (Triptodur) — July
The FDA has approved the gonadotropin-releasing hormone agonist triptorelin in a 6-month formulation for the treatment of central precocious puberty, Arbor Pharmaceuticals and Debiopharm International announced in a press release.
Triptorelin (Triptodur) is an extended-release injectable suspension approved to treat central precocious puberty in children aged 2 years and older. The approval marks the first new treatment formulation for U.S. children in 6 years and is the first GnRH agonist available for twice-yearly dosing in the U.S., according to the companies. Read more.
Victoza (liraglutide) — August
The FDA today approved an expanded indication for the GLP-1 receptor agonist liraglutide to include language in the prescribing information that the drug can reduce risk for major adverse cardiovascular events, myocardial infarction, stroke and cardiovascular disease in adults with type 2 diabetes and established CVD, according to a press release from Novo Nordisk.
The decision is based on results from the LEADER trial, which demonstrated a 13% reduced risk for a three component endpoint of CV death, nonfatal MI and nonfatal stroke with liraglutide (Victoza, Novo Nordisk) compared with placebo (P = .01). Read more.
Afrezza (insulin human inhalation powder) — October
The FDA recently approved updated prescribing information for the only available inhaled insulin powder to include new clinical data that was presented at the American Diabetes Associations’ Scientific Sessions in 2016, according to a release from MannKind Corporation.
The inhaled rapid-acting mealtime insulin (Afrezza, MannKind) is approved to improve glycemic control in adults with type 1 and type 2 diabetes. Read more.
Bydureon BCise (exenatide extended-release) — October
The FDA recently approved AstraZeneca’s GLP-1 receptor agonist exenatide extended-release injection in a once-weekly single-dose autoinjector device for the treatment of adults with type 2 diabetes, according to a press release from AstraZeneca.
The exenatide extended-release injection (Bydureon BCise) is a new formulation of the current exenatide extended-release injection (Bydureon). The new formulation has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the drug and has been shown to reduce blood sugar levels and promote weight loss, according to the release. Read more.
Ozempic (semaglutide) — December
The FDA approved a new drug application for the GLP-1 receptor agonist semaglutide for the treatment of type 2 diabetes in adults, Novo Nordisk announced in a press release.
The once-weekly semaglutide injection (Ozempic), available in 0.5-mg and 1-mg formulations in a prefilled pen, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It can be taken at any time of day, with or without meals. Read more.
Macrilen (macimorelin) — December
The FDA has approved the oral ghrelin agonist macimorelin to be used in the diagnosis of patients with adult growth hormone deficiency, according to a press release from Aeterna Zentaris.
Macimorelin (Macrilen) will be used to stimulate the secretion of GH from the pituitary gland into the circulatory system. Read more.
Ertugliflozin — December
The FDA approved three new medicines containing the SGLT2 inhibitor ertugliflozin with the indication of improving glycemic control in adults with type 2 diabetes, according to the agency’s Center for Drug Evaluation and Research.
Steglatrotm (oral ertugliflozin) and the fixed-dose combinations Steglujan (ertugliflozin and sitagliptin [Januvia, Merck]) and Segluromet (ertugliflozin and metformin). The three formulations will be made available in early 2018, according to Merck and Pfizer.
The approvals are based on studies in the VERTIS clinical development program of ertugliflozin, including VERTIS MONO, VERTIS Factorial and VERTIS SITA2, results of which were presented in 2016. The full VERTIS clinical development program includes nine phase 3 trials with approximately 12,600 adults with type 2 diabetes. Read more.
Admelog (insulin lispro 100 U/mL) — December
The FDA announced the approval of Admelog, the first follow-on short-acting insulin indicated to improve blood glucose control in adult and pediatric patients with type 1 or type 2 diabetes, according to an agency press release.
The approval of follow-on insulin lispro (Admelog, Sanofi) was achieved through an abbreviated approval pathway under the Food, Drug and Cosmetic Act. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective, or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified. The use of abbreviated pathways can reduce drug development costs so products can be offered at a lower price to patients. Read more.