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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Dec 15, 2008

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