FDA again delays NDA for Eli Lilly/Daiichi Sankyo's potential blockbuster prasugrel
The US Food and Drug Administration has further delayed the approval of the New Drug Application for US drug major Eli Lilly and Japanese pharmaceutical firm Daiichi Sankyo's antiplatelet agent prasugrel beyond the most recent goal date of September 26.
The patent for Lilly's lead drug Zyprexa (olanzapine), which contributed a quarter of the firm's $18.6 billion revenue last year, expires in 2011. It is hoped that prasugrel will replace the drug's sales when launched. Lilly's shares fell 4% to $44.91 in after-hours trading after the news broke.
The drug, to be sold as Effient, was previously granted priority review in February, but received a three-month delay based on supplemental information provided during the review period (Marketletters passim).
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