Post by derek2 on Sept 29, 2014 17:41:32 GMT -5
www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdf
Your deferred pediatric study required by section 505B(a) of the FDCA is a required
postmarketing study. The status of this postmarketing study must be reported annually according
to 21 CFR 314.81 and section 505B(a)(3)(B) of the FDCA. This required study is listed below.
2166-1 An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability
dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive)
with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label,
randomized, controlled trial comparing the efficacy and safety of prandial Afrezza
Reference ID: 3533688
NDA 022472
Page 3
to prandial subcutaneous insulin aspart used in combination with subcutaneous
basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type
2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a
52-week randomized intervention phase.
The timetable you submitted on June 23, 2014 , states that you will conduct this
study according to the following schedule:
Final Protocol Submission: January 2015
Study Completion: July 2020
Final Report Submission: January 2021
Your deferred pediatric study required by section 505B(a) of the FDCA is a required
postmarketing study. The status of this postmarketing study must be reported annually according
to 21 CFR 314.81 and section 505B(a)(3)(B) of the FDCA. This required study is listed below.
2166-1 An open-label pharmacokinetic (PK), and multiple-dose safety and tolerability
dose-titration trial of Afrezza in pediatric patients ages 4 to 17 years (inclusive)
with type 1 diabetes (Part 1), followed by a prospective, multicenter, open-label,
randomized, controlled trial comparing the efficacy and safety of prandial Afrezza
Reference ID: 3533688
NDA 022472
Page 3
to prandial subcutaneous insulin aspart used in combination with subcutaneous
basal insulin in pediatric patients 4 to 17 years old (inclusive) with type 1 or type
2 diabetes (Part 2). Part 2 of the trial should include a 4-week run-in phase and a
52-week randomized intervention phase.
The timetable you submitted on June 23, 2014 , states that you will conduct this
study according to the following schedule:
Final Protocol Submission: January 2015
Study Completion: July 2020
Final Report Submission: January 2021
