It would appear that night time glucose levels, which derailed AERx, weren't measured in Exubera long term safety studies. From this year's ADA meeting:
>>Sustained Long-Term Efficacy and Safety of Inhaled Insulin during 4 Years of Continuous Therapy
Abstract Information
Abstract Number: 486-P
Authors: JAY SKYLER, FOR THE EXUBERA® PHASE II STUDY GROUP
Institution: Miami, FL
Results: Inhaled insulin has shown encouraging efficacy and safety data in short-term clinical trials. This study examined whether these favorable results are maintained in the long term. Continued open-label inhaled insulin therapy was offered to patients with diabetes who had completed any of three 3-month, randomized, controlled clinical trials (type 1, insulin-treated type 2 or type 2 diabetes uncontrolled on oral agents [OAs]). A total of 204 patients entered the extension, with 159 electing to stay on inhaled insulin (INH) or switch from comparator treatments and 89 patients having received at least 4 years of INH therapy. A small group of patients (n=23) on OAs or subcutaneous insulin was followed for up to 2 years as well. Mean (± SD) HbAì1cí was 8.23 ± 1.21% after 4 years in INH patients compared with 8.71 ± 1.49% at the start of INH treatment. Inhaled insulin dose increased slightly from 0.15 mg/kg after 3 months of treatment to 0.18 mg/kg after 4 years. The rate of overall hypoglycemia decreased from 2.58 episodes/subject month (first 4 weeks of INH treatment) to 1.50 after 4 years (final 6 months). Annualized changes in the lung function parameters FEVì1í and DLìCOí (mean ± SE) in INH patients over 4 years were -0.057 ± 0.004 L/yr and -0.376 ± 0.067 mL/min/mmHg/yr, respectively. Corresponding declines in non-INH patients (based on 2-year data only) were -0.071 ± 0.023 L/yr and -0.673 ± 0.423 mL/min/mmHg/yr, respectively. In conclusion, glycemic control and pulmonary function are well maintained during long-term continuous inhaled insulin therapy.<<
So my question is, why has ARDM/Novo made this measurement while NKTR and partners have not? Will the FDA want this parameter? I would think that if the former thought it was appropriate to delay development while investigating this issue, that the FDA would surely want to look at it from all comers. I wonder what others are thinking. FBR downgraded NKTR today, but I can't find the rationale. The results appear pretty good, absent the above measurement.
Thanks for any thoughts from anyone on this.
Cheers, Tuck |
