The Coats effect.
Lexicon slams FDA over hearing denial following a CRL for its SGLT2 inhibitor candidate – Endpoints News
https://endpts.com/lexicon-slams-fd...wing-a-crl-for-its-sglt2-inhibitor-candidate/
Zachary Brennan
Senior Editor
Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.
The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.
“The data demonstrated that the addition of sotagliflozin to insulin is associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency,” the agency said in a rare explanation of its complete response letter. “Time-to-event analyses of the clinical trial data showed earlier development of DKA in sotagliflozin-treated patients than in patients assigned to placebo, without evidence that the risk stopped increasing over time.”
Lexicon slams FDA over hearing denial following a CRL for its SGLT2 inhibitor candidate – Endpoints News
https://endpts.com/lexicon-slams-fd...wing-a-crl-for-its-sglt2-inhibitor-candidate/
Zachary Brennan
Senior Editor
Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.
The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.
“The data demonstrated that the addition of sotagliflozin to insulin is associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency,” the agency said in a rare explanation of its complete response letter. “Time-to-event analyses of the clinical trial data showed earlier development of DKA in sotagliflozin-treated patients than in patients assigned to placebo, without evidence that the risk stopped increasing over time.”