Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
A delay in the submission of basal insulin peglispro to regulatory agencies has been announced by Eli Lilly and Company, according to a press release.
The delay goes beyond the first quarter of 2015 and includes filing with the FDA and European Medicines Agency.
The delay will give Lilly a chance to generate additional clinical data in order to gain a better understanding of the effects basal insulin peglispro may have on liver fat in phase 3 trials. The clinical trials to date, which include more than 6,000 patients with type 1 and 2 diabetes, were treated for up to 18 months with no drug-induced liver impairment reported.
http://www.healio.com/endocrinology...in-peglispro-to-regulatory-agencies-announced
The delay goes beyond the first quarter of 2015 and includes filing with the FDA and European Medicines Agency.
The delay will give Lilly a chance to generate additional clinical data in order to gain a better understanding of the effects basal insulin peglispro may have on liver fat in phase 3 trials. The clinical trials to date, which include more than 6,000 patients with type 1 and 2 diabetes, were treated for up to 18 months with no drug-induced liver impairment reported.
http://www.healio.com/endocrinology...in-peglispro-to-regulatory-agencies-announced