Lilly Jardiance treatment for type 1 diabetes rejected by FDA!

Currently, empagliflozin 10mg and 25mg are listed under the brand name Jardiance (Chinese product name: OtangJing ®, generic name: empagliflozin, engrenet) for the treatment of adult patients with type 2 diabetes.
empagliflozin 2.5mg is an SGLT2 inhibitor class sugar-lowering drug developed by Bollinger Ingham and Lilly, which has come up with a separate brand name for the treatment of T1D patients. "The challenges of managing blood sugar levels in people with type 1 diabetes, as well as the desire for new treatments, reveal significant unmet medical needs in the diabetes community," said Mohamed Eid, senior vice president of clinical development and medical affairs at
's Briginger Ingham Heart Metabolism and Respiratory Medicine.
we remain committed to continuing research therapy to improve the prognosis of adult patients with heart and kidney metabolic diseases, including diabetes.
" empagliflozin 2.5mg sNDA for the treatment of type 1 diabetes, incorporating data from the EASE Phase III project.
the project included two multi-country, double-blind, placebo-controlled Phase III studies that evaluated the efficacy, safety and tolerance of empagliflozin as an insulin therapy aid for T1D adult synopsis, of which: (1) EASE-2 (NCT02414958) study evaluated empagliflozin 10mg, 25mg dose, placebo as a drug for 52 weeks, the main end point of insulin treatment Changes in the relative baseline of weekly blood sugar levels (A1C), 720 patients in the study, and (2) EASE-3 (NCT02580591) study assessed the change of empaglisin 2.5mg, 10mg, 25mg dose, placebo as an assisted insulin drug for 26 weeks, the main endpoint of which was the change in the relative baseline of the blood glucose level (A1C) in the study group.
results from the project showed a statistically significant reduction (0.28%) in the blood sugar level of A1C in the empagliflozin group compared to the insulin-placebo treatment group.
secondary endpointshowed a decrease in the weight (1.8 kg) and systolic pressure (2.1mmHg) of the empagliflozin group compared to the insulin-placed treatment group.
safety, the rate of adverse events was similar in 2 groups and the number of ketoacidosis incidents was comparable in 2 groups.
Jardiance (O'Donnell®, Engrenet) is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor class.
emerging SGLT-2 inhibitor stakes have been shown to block the reabsorption of glucose in the kidneys, excreting excess glucose into the body, thus achieving a lower blood sugar level, and the reduced sugar effect does not depend on beta cell function and insulin resistance.
in addition to having a clear sugar-lowering effect, the drug can also bring additional benefits of weight loss, lower blood pressure, and lower uric acid.
Good safety in Jardiance reduces the risk of cardiovascular events in diabetic sourmisons, and is the world's first type 2 diabetes drug that has been shown to reduce the risk of cardiovascular death.
Jardiance was approved for treatment of type 2 diabetes in August 2014.
at the end of 2016, Jardiance was again approved to reduce the risk of cardiovascular death for people with type 2 diabetes with concurrent cardiovascular disease.
approval, Jardiance has become the world's first approved sugar-lowering drug to reduce the risk of cardiovascular death in people with type 2 diabetes.
so far, several SGLT2 inhibitors have been on the market and have been a great success in the treatment of type 2 diabetes.
Jardiance is a heavyweight SGLT2 inhibitor with global sales of $2.12 billion in 2018, accounting for more than 50% of SGLT2 inhibitors.
in recent years, the Lilly-Bollinger Ingham Alliance has been working to expand Jardiance's indications, including the treatment of type 1 diabetes, heart failure, and chronic kidney disease.
note that the Bollinger Ingerheim-Lilly Alliance is not the only player involved in The Treatment of Type 1 Diabetes with SGLT inhibitors.
first half of 2019, AstraZeneca Farxiga (Chinese brand name: Andatang, generic name: dapagliflozin, Dagliflozin, SGLT-2 inhibitors), Sanofi/Lexicon co-developed Zyquista (sotagliflozin, Soglinet, SGLT-1 The eu-approved treatment of adults with type 1 diabetes is the eu-approved treatment of adults with type 1 diabetes, and the two drugs are: oral complementary treatment as insulin, used for insulin treatment but poor blood sugar level control and body mass index (BMI) of 27kg/m2 (overweight or obese) T1D adult patients, improving their blood sugar control.
, Farxiga has also received approval for T1D indications in Japan.
December 2018, Astellas' sugar-lowering drug Suglat (ipragliflozin L-proline, iglinet L-proline, SGLT-2 inhibitors) was approved in Japan for the treatment of T1D adult patients.
, Johnson and Johnson is also developing Invokana (canagliflozin, kagliflozin, SGLT-2 inhibitors) for the treatment of T1D.
Although several SGLT inhibitors have been approved for the treatment of type 1 diabetes in the European Union and Japan, no SGLT inhibitors have been approved for T1D indications in the United States.
March and July 2019, Zynquista and Farxiga were denied treatment for T1D by the FDA because of a higher percentage of patients in the experimental group who had ketoacidosis (DKA) compared to the placebo group.
DKA is a common diabetes complication with a higher incidence in T1D patients than in T2D patients.
original source: US FDA issues complete response for empagliflozin 2.5 mg adjunct to insulin for adults with type 1 diabetes.