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FDA approves an expanded indication for BYETTA injection

October 31, 2009

Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is after this approved for use for example a stand-alone medication (monotherapy) along with diet and pursue to become better glycemic manage in adults with type 2 diabetes. Previously, it was approved for employment only in patients who were also distress other customary diabetes medications and had not achieved adequate glycemic command.

"The expanded indication gives physicians the election to prescribe BYETTA taken in the character of a first-line method of treating, increasing the number of patients who may favor from the medication and providing an opportunity to enjoyment patients with BYETTA earlier in the disease," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "Type 2 diabetes is a complex disease, in this way it is essential that healthcare professionals and their patients have a wide collocation of treatments that can effectively restrain blood starch-sugar levels."

The approval of BYETTA as a monotherapy treatment was based on a clinical ponder of patients by type 2 diabetes who were unable to execute glycemic control through diet and exercise alone. Study findings showed that patients treated with 5 mcg or 10 mcg of BYETTA as monotherapy reduced their A1C, a indefinite quantity of average blood sweeten too three months, by dint of. 0.7 percentage points and 0.9 percentage points, respectively, and lost 6.0 pounds and 6.4 pounds, respectively. Results of this study were published in Clinical Therapeutics in August 2008.

Among treatment-emergent adverse events, nausea was reported by the greatest incidence (5 mcg, 3 percent; 10 mcg, 13 percent). Hypoglycemia was reported in 5 percent of patients taking 5 mcg and 4 percent of patients taking 10 mcg, with no severe hypoglycemic events.

In addition to the monotherapy indication, the FDA approved changes to the BYETTA Prescribing Information to incorporate updated safety information, including pancreatitis-related language added to the Warnings and Precautions segment. This update addresses the alert issued by the FDA in August 2008. The reinvigorated label also expands upon existing language regarding application of BYETTA in patients by renal impairment. In adding, the label has been amended to proportion the format the FDA currently uses for Prescribing Information. This label update is existence communicated to physicians via a "Dear Healthcare Professional" letter, which will be available at www.BYETTA.com.

"Patient safety is our foremost concern at Amylin and Lilly, and the BYETTA Prescribing Information represents one important distance to communicate the information that healthcare professionals and patients destitution in rank to use the medication safely and effectively," Kolterman continued. "Thus, the updated label offers the greatest number general intelligence about the benefit-risk profile of BYETTA as a foundational therapeutic choice for people by type 2 diabetes."

BYETTA has been used by else than one million patients seeing that market introduction in 2005. It has a proven chronicle with more than 10 a thousand thousand prescriptions written and 6.5 years of clinical experience.

SOURCE Amylin Pharmaceuticals, Inc.

Written by Samanta · Filed Under Actoplus