Twice rejected by the FDA, diabetes medication Bydureon is under review in the U.S. for the third time with a decision to be announced next month. Bydureon is a once-weekly version of the injectable diabetes medication Byetta, which has been available in the U.S. since June 2005 and is used in more than 70 countries worldwide for the treatment of type 2 diabetes. Byetta is injected, twice a day. The active ingredient in both Byetta and Bydureon is Exenatide, a glucagon-like peptide 1 receptor agonist.
Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly and Co. (LLY) and Alkermes plc (ALKS) have been working together to develop Bydureon. Last month, due to a legal spat, Amylin and Lilly ended their drug development partnership that was formed in 2002 and Amylin gained full rights to Byetta and Bydureon. Amylin will select another partner for outside-U. S. operations for the Exenatide franchise. However, the drug-delivery partnership between Amylin and Alkermes, which has been in effect since 2000, remains intact.
The New Drug Application for Bydureon was submitted in May 2009 based on data from a clinical trial program dubbed DURATION, as well as more than seven years of clinical experience with Byetta. However, much to the disappointment of many, the FDA issued a complete response letter in March 2010 requesting the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy, or REMS, and clarification of existing manufacturing processes.
A reply to the complete response letter issued for the Bydureon NDA was submitted in April of 2010 and it was classified as a Class 2 resubmission with a decision date on October 22, 2010. But Bydureon was unlucky second time too as the FDA issued a complete response letter again and sought a thorough QT (tQT) study on cardiac safety concern.
In response to the second complete response letter issued for Bydureon, a reply was submitted to the FDA in July of this year, which included results from a completed thorough QT (tQT) study, showing that Bydureon , at and above therapeutic levels, did not prolong the corrected QT interval in healthy individuals. A prolonged QT interval may increase total and cardiovascular mortality due to life-threatening ventricular arrhythmias and sudden death.
The reply submitted in response to the second complete response letter is also a Class 2 resubmission and has a decision date set for January 28, 2012.
If approved, Amylin believes Bydureon will be an important new option for type 2 diabetes patients, as the first once-weekly treatment available in the U.S.
Bydureon was approved in the European Union in April of this year and was launched there in July. The UK health watchdog, NICE, has recommended Bydureon in triple therapy regimens (in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedionei) as a treatment option for people with type 2 diabetes. A final guidance to this effect is scheduled to be published in February 2012.
Though in a head-to-head study, which compared Bydureon with Novo Nordisk's Victoza, it has been proven that Bydureon is inferior to Victoza in its blood sugar-lowering capacity, Bydureon has an advantage of reduced frequency of dosing. Victoza, which is also a glucagon-like peptide 1 receptor agonist, requires once daily injections while Bydureon is just once a week injection drug. Sales estimates for Bydureon range anywhere from $1 billion to $6 billion. Byetta had global sales of $710.2 million in 2010, down 11 percent from the previous year.
Diabetes is the seventh leading cause of death in the U.S. About 25.8 million Americans and 366 million people worldwide are reported to have diabetes. Type 2 diabetes* accounts for 90%-95% of all diagnosed cases of diabetes. (*Type 1 diabetic patients lack insulin; type 2 diabetic patients have either too little insulin or cannot use insulin effectively).
Even more alarming is that an estimated 552 million, or one out of every 10 adults, could have diabetes by 2030, according to the International Diabetes Federation.
Will the FDA say 'YES' at least this time to a revolutionary treatment for diabetes - Bydureon? Stay tuned for this binary event...
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