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

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