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biomaven0

04/25/12 10:24 PM

#140828 RE: pcrutch #140827

Sounds like Takeda is still hoping to not have to wait for the outcomes trial. If they do, then any possible approval is likely three or four years out.

Furiex has an interesting IB-d drug - not sure what else they have.

Peter
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DewDiligence

07/27/12 4:36 PM

#146142 RE: pcrutch #140827

Takeda resubmits NDAs for Alogliptin and Alogliptin/Actos combination:

http://finance.yahoo.com/news/takeda-resubmits-drug-applications-united-183000913.html

The FDA issued a CRL on these NDAs in Apr 2012, but stopped short of demanding a new trial (#msg-74854335). Alogliptin is a DPP-4 inhibitor, i.e. from the same class as MRK’s Januvia. Actos is a big-selling drug that Takeda has been marketing since the 1990s; it goes off-patent in the US in 2016.