FDA Unlikely to Approve Byetta Monotherapy Soon

Byetta’s makers submitted it for regulatory review in the first quarter of this year and hoped for a relatively quick FDA approval.

Dec 15, 2008

Hopes that the U.S. Food and Drug Administration would move soon to make the diabetes drug Byetta a monotherapy are fading. It now appears that the FDA will extend its review of the drug into 2009.

(A monotherapy is a therapy in which only one drug, rather than two or more, is prescribed to treat a disease or condition. Currently people who take Byetta must also take metformin or a sulfonylurea.)

Byetta's makers, Amylin Pharmaceuticals, Inc., and Eli Lilly & Co., submitted it for regulatory review in the first quarter of this year and were hoping for relatively quick agency approval.

It also appears that Amylin and Lilly will hold off on asking the FDA to study a long-acting form of Byetta, due to the agency's recent concerns over cases of pancreatitis associated with use of the drug.

People who take Byetta typically inject 10 mcg twice daily, within an hour before their morning or evening meal. The long-term version, now in Phase 3 trials at selected hospitals and clinics nationwide, is taken once weekly.

That form of Byetta uses tiny time-release capsules that leave small lumps under the skin where they have been injected. The lumps decrease in size as the capsules dissolve and release the drug into the bloodstream.

The FDA's potential concern is that if Byetta can be shown to be a causative agent in some cases of pancreatitis, the presence of time-release capsules that continue to place the drug into the body could aggravate the condition.

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Categories: Byetta, Diabetes, Diabetes, Food, Metformin

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Posted by Anonymous on 16 December 2008

Incorrect. Amylin and Lilly received the "go" last week from the FDA that it will accept the data they wish to submit based upon clinical extension trials for the long acting Byetta. The concern was that the pens were made at another facility rather than the factory in Ohio which was being built at that time. The concern was not pancreatitis associated with the drug. The FDA stated they can not say without a doubt whether or not Byetta can induce pancreatitis. As many know, pancreatitis in a diabetic is a common comorbidity of the disease. Patients who have taken insulin have also developed cases of pancreatitis.

Posted by Anonymous on 22 December 2008

I agree, despite what the tort bar may think, there doesn't appear to be a statistically-valid association with pancreatitis. Even if it was an issue, it would be nice for LAR to be available for those who have shown good tolerance and no complications associated with daily Byetta use.

Posted by Anonymous on 13 January 2009

According to Amlin Pharma, the manufacturer of byetta, they expect the FDA to announce their decision about once weekly Byetta in the first quarter of 2009. This was published in their press release issued 1/13/09.

Posted by Anonymous on 13 January 2009

My previous post was incorrect, Amlin expects word on the use of byetta as a monotherapy in Q1 2009, the decision on once weekly byetta is not expected this year.

Posted by Anonymous on 13 January 2009

Amlin expects a decision by the FDA on monotherapy usage of Byetta, not once weekly Byetta.

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