Amylin and Lilly gets thumbs-up from European Union for new Byetta use

Despite splitting with Lilly on the product collaboration, Amylin says it intends to provide uninterrupted patient supply in all markets where exenatide products are launched, as well as additional markets in the future.

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SAN DIEGO and INDIANAPOLIS—Amylin Pharmaceuticals Inc. and Eli Lilly andCo. announced March 23 that the European Commission has grantedmarketing authorization to BYETTA (exenatide twice-daily) as an adjunctivetherapy to basal insulin, with or without metformin and/or Actos(pioglitazone), for the treatment of type 2 diabetes in adults who have notachieved adequate glycemic control with these agents.
"The marketing authorization for the use ofByetta with basal insulin provides a new option for the many patients with type2 diabetes who are not achieving treatment goals," said Dr. Christian Weyer,senior vice president of research and development at Amylin."In a clinical trial, patients using fixed-dose Byetta with titrated basalinsulin achieved better postprandial and overall glycemic control, withoutweight gain or an increased risk of hypoglycemia, compared to patients usingtitrated basal insulin without Byetta."
However, while the companies jointly announced the news, they won't be jointly marketing it, having amicably terminated their decade-long collaboration in November 2011 . As part of thetransition plan outside the United States, Amylin will assume responsibility forexenatide product commercialization efforts on a market-by-market basis by theend of 2013. Amylin will work with Lilly on plans for markets outside the United Statesduring the transition period.
Amylin says it "intends to provide uninterrupted patientsupply in all markets where exenatide products are launched, as well asadditional markets in the future."
Both companies says they are committed to ensuring aseamless transition of global product responsibility to Amylin whilemaintaining continuity of patient care. Amylin anticipates working with one ormore partners outside the United States to maximize the global potential ofthe product
The main study included in the European Union (EU) marketingauthorization submission package was a double-blind, 30-week clinical trialpublished in Annals of Internal Medicine. In the study, Byetta at 10 microgramsor placebo was added to existing insulin glargine therapy (with or withoutmetformin, pioglitazone or both), which was titrated to achieve target fastingglucose levels. At study entry, patients who may have been at increased risk ofhypoglycemia (hemoglobin A1C less than or equal to 8 percent) reduced their dose ofinsulin glargine by 20 percent. Five weeks after randomization, all patientshad insulin doses titrated to achieve target fasting glucose levels. The primaryendpoint was reduction in A1C, a measure of average blood sugar over threemonths; secondary endpoints included change in body weight along with otherparameters of glucose control, cardiovascular health, hypoglycemia andpatient-reported outcomes.
After 30 weeks of treatment, Byetta demonstrated astatistically significant reduction in A1C compared to placebo, lowering A1C by1.7 percentage points from a baseline of 8.3 percent. Patients treated withoptimized insulin glargine plus placebo experienced a 1 percentage pointdecrease in A1C from a baseline of 8.5 percent.
Patients who added Byetta totheir insulin glargine regimen saw their weight decrease by an average of 4pounds, compared with an increase of 2 pounds in patients who were treated withoptimized insulin glargine plus placebo; however, Byetta is not indicated for themanagement of obesity and weight loss was a secondary endpoint in the trial.
Change in fasting glucose and hypoglycemia incidence were similar betweentreatment groups.
Thirteen Byetta recipients and one placeborecipient (9 percent vs. 1 percent) discontinued the study because of adverseevents (p less than 0.010). Rates of nausea (41 percent vs. 8 percent),diarrhea (18 percent vs. 8 percent), vomiting (18 percent vs. 4 percent), headache(14 percent vs. 4 percent) and constipation (10 percent vs. 2 percent) werehigher with Byetta than with placebo. Major hypoglycemia occurred twice in onepatient receiving insulin glargine without Byetta.

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