FDA calls for more tests of PPD’s proposed diabetes drug
The long expected formal delay of a new drug targeting Type 2 diabetes being developed in part by Pharmaceutical Product Development (Nasdaq: PPDI) is official.
PPD, which is based in Wilmington, and Japan-based Takeda Pharmaceutical Company said a new drug application for the drug alogliptin had been rejected. The FDA has formally asked for more tests.
Alogliptin is intended to treat diabetes as part of a regime including diet and exercise.
PPD disclosed in March that the FDA said there was not sufficient clinical data to support criteria for cardiovascular risk requirements announced in December.
Following that announcement, PPD pushed back an anticipated $25 million milestone payment for the drug this year. The FDA also pushed back the NDA process last fall, citing internal resource constraints.
Featured
Hot Off The Wire
- Red Hat's new Fedora lead; Cree LED breakthrough; Google, Cisco top 'green' list; Oracle rejects SAP settlement; Yahoo board shakeup
- Will Cisco report progress in its turnaround efforts?
- Cisco server fire threat; Lenovo Android upgrade; cloud startup vs. Cisco; Epic's Blesinski to host awards; Google 'Solve for X'
E-mail Preferences
