As if integration issues from the large acquisition of Wyeth weren't enough, here's another reason to worry about Pfizer
The pharmaceutical giant originally got a "not-approvable letter" for using Lyrica as a treatment for anxiety back in 2004. Under the new terminology, this time around, the company received a "complete response letter." By any name, it's still a rejection.
As is typical with pharmaceutical companies, Pfizer didn't elaborate much on the rejection, simply saying that the FDA felt that "data contained in the [New Drug Application] were insufficient to support approval." Whether that means an additional trial is needed remains to be seen.
Pfizer is still holding out hope that the FDA will approve the drug as an add-on therapy for anxiety, even though it wouldn't approve it as a monotherapy.
Lyrica is currently approved as a treatment for fibromyalgia, nerve pain, and as an add-on treatment for seizures. Its biggest rival, Eli Lilly's
It is rather weird, though, that Pfizer couldn't get Lyrica past the FDA. Large pharmaceutical companies like Pfizer, Merck
Maybe the FDA has moved the goalposts for approval -- it wouldn't be the first time -- but Lyrica's latest rejection just seems like one more stumble from giant Pfizer. You know what they say: The larger they are, the harder they fall.
For a contrarian view, Adam Wiederman explains why pessimism can be a good indicator for successful investing.