FDA's "Complete Response" Letter For Byetta LAR Isn't Too Onerous, Amylin Says
This article was originally published in The Pink Sheet Daily
Analysts still expect an approval and launch by year end of long-acting exenatide, now branded as Bydureon.
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Changes in the manufacturing site and production scale for exenatide extended-release complicated FDA’s review of Bydureon, Amylin’s follow-on agent to Byetta, and late-rising questions about the drug’s QT effects made FDA revisit its earlier conclusion that the investigational and commercial formulations were comparable. The agency’s decision to require additional clinical data in a second “complete response” letter suggests biosimilar sponsors will face a similarly high clinical hurdle.
Twice delayed by “complete response” letters, the drug’s approval gives Amylin a once-weekly GLP-1 analog, the longest-acting drug in its class.
There’s more than meets the eye to the story of the seemingly surprising “complete response” letter for Amylin’s ultra-high-profile once-weekly diabetes injectable Bydureon.