FDA approval for Lilly’s Bydureon delayed until Jan 28

Subsequent to a delay of one year for the approval of once-per-week diabetes drug Bydureon, the United States Food and Drug Administration expects to take another 5 months until January to make a verdict.

After the submission of a new application in July, the drug-developing companies, Amylin Pharmaceuticals Inc., Eli Lilly & Co., and Alkermes Inc., said that the agency is expected to make a decision for Bydureon by Jan 28.

With the decline in FDA approval of Bydureon in October, the companies were asked by the agency to conduct a systematic study to assess the effects of high Bydureon doses on the heart rates of patients. The companies were also requested to submit study data that evaluated the efficacy as well as the labeling of safety and efficacy of the commercial drug formulation. The data from those studies is being reviewed by the US regulatory agency.

The same ingredient as Byetta (the diabetes drug by Lilly and Amylin) is contained in Bydureon that also has the ingrained technology created by Alkermes to release the drug over a duration of one week for well-suited dosing. Bydureon was approved by the European Union regulators in June.

With the sharp decline in markets on Wednesday, shares of Amylin plunged 7.5 percent to $9.69 and those of Alkermes fell 5.6 percent to $13.91, although, both remained unchanged in aftermarket trading. During the day, Eli Lilly shares plummeted 3.2 percent to $34.49 and hiked 4 cents to $34.53 in after hours trading.