July 22, 2024

Business Briefing | HEALTH: Amylin to Resubmit Diabetes Treatment to F.D.A.

Amylin Pharmaceuticals, a biopharmaceutical company, said its experimental diabetes treatment Bydureon will be resubmitted for regulatory approval in the United States this quarter. The company, based in San Diego, and its partners, Eli Lilly Company of Indianapolis and Alkermes of Waltham, Mass., announced late Thursday that a study requested by the Food and Drug Administration did not tie Bydureon to dangerous changes to heart rhythm. The data were released in summary form on June 24. The F.D.A. rejected Bydureon, a longer-acting form of the companies’ Byetta medicine, in October over concerns that high doses might cause heart risks. The companies said Thursday that they planned to refile their application with the new data on heart rhythm in the third quarter, sooner than expected.

Article source: http://feeds.nytimes.com/click.phdo?i=dbbff3c8096a183df3ac3df9b8672aab

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