Pramlintide is a human amylin analog, under development by Amylin (originally in collaboration with Johnson & Johnson), as an adjunct with insulin for the potential prevention of complications of type I diabetes, and as a single agent for type II diabetes , , . In December 2000, Amylin submitted a US NDA seeking approval to market pramlintide as an adjunctive therapy for type 1 and 2 diabetics using insulin ; the application was accepted for review by the FDA in January 2001 , and was scheduled for review by the Endocrinologic and Metabolic Drugs Advisory Committee on July 26 2001 . In May 2001, Amylin submitted an MAA for pramlintide to the EMEA  and in October 2001, Amylin received an approvable letter from the FDA for both Type I and insulin-using Type II diabetes; however, at this time, discussions with the FDA were ongoing regarding additional clinical work that was required before the NDA would be approved .
Pramlintide (Amylin) / D. Barlocco. - In: CURRENT OPINION IN INVESTIGATIONAL DRUGS. - ISSN 0967-8298. - 2:11(2001), pp. 1575-1581.
BARLOCCO, DANIELA (Primo)
|Settore Scientifico Disciplinare:||Settore CHIM/08 - Chimica Farmaceutica|
|Data di pubblicazione:||2001|
|Appare nelle tipologie:||01 - Articolo su periodico|