2017 年美國 FDA 通過多少內分泌新陳代謝相關的藥物?

這幾年由於血糖藥的 CV safety trials 的結果陸續發表,算是糖尿病界非常蓬勃發展發展的時間(要唸的書更多了@@)。不過除了糖尿病,還有內分泌疾病相關藥物的發展其實也默默地進行。
我們就趁此機會來回顧去年(2017)美國 FDA 通過了哪些本科相關藥物(看有哪些東西沒念到的!)。
算起來共 10 種藥,糖尿病才 4 種!
1. Etelcalcetide(Parsabiv™)
Date of approval:2017/02/07
Mechanism:Calcium-sensing receptor agonist
Indication:secondary hyperparathyroidism in adults patients with chronic kidney disease on hemodialysis.
Company:KAI PHARMS INC
2. Dapagliflozin/Saxagliptin(10/5) combination(Qtern ™)
Date of approval:2017/02/27
Mechanism:SGLT2 inhibitor and DPP4 inhibitor
Indication:adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.
Company:ASTRAZENECA AB
3. Deflazacort(Emflaza ™)
Date of approval:2017/02/09
Mechanism:corticosteroid
Indication:for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
Company:PTC THERAP
4. Telotristat ethyl(Xermelo ™)
Date of approval:2017/02/28
Mechanism:Tryptophan hydroxylase inhibitor
Indication:for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog(SSA) therapy in adults inadequately controlled by SSA therapy.
Company:LEXICON PHARMS INC
5. Abaloparatide(Tymlos ™)
Date of approval:2017/04/28
Mechanism:human parathyroid hormone-related peptide (PTHrP(1-34))analogue
Indication:for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy
Company:RADIUS HEALTH INC
6. Triptorelin(Triptodur ™)
Date of approval:2017/06/29
Mechanism:gonadotropin-releasing hormone (GnRH) agonist
Indication:for the treatment of pediatric patients 2 years and older with central precocious puberty
Company:Arbor Pharmaceuticals, LLC
7. Exenatide extended-release(Bydureon BCise ™)
Date of approval:2017/10/20
Mechanism:GLP-1 receptor agonist
Indication:adjust to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Company:ASTRAZENECA AB
8. Semaglutide(Ozempic ™)
Date of approval:2017/12/05
Mechanism:GLP-1 receptor agonist
Indication:adjust to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Company:NOVO NORDISK INC
9. Macimorelin(Macrilen)
Date of approval:2017/12/20
Mechanism:growth hormone (GH) secretagogue receptor agonist
Indication:for the diagnosis of adult growth hormone deficiency.
Company:Aeterna Zentaris Inc.
10. Ertugliflozin(Steglatro ™)
Date of approval:2017/12/19
Mechanism:SGLT2 inhibitor
Indication:adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Company:MERCK SHARP DOHME