Amylin Halts Development Of Symlin With Approved Appetite Suppressants
This article was originally published in The Pink Sheet Daily
The 2009 filing timeline for once-weekly exenatide could be hastened if FDA does not require bioequivalence data, firm says.
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Subjects taking pramlintide/metreleptin lost a significant 12.7 percent of body weight compared with 8.4 percent for subjects on pramlintide alone.
Firms expect to file NDA by end of first half 2009.
Lilly/Amylin'sByetta type 2 diabetes agent is "approvable" at FDA as a stand-alone therapy in conjunction with the April 29 approval of exenatide as an adjunct to other oral treatments, the firms said