In case you weren't aware, tomorrow is "World Osteoporosis Day" or WOD, for short, as the International Osteoporosis Foundation hilariously refers to it, but biotech Amgen won't be celebrating the occasion.
Had the FDA today approved AMGN's twice-a-year injectable bone drug, Prolia, the champagne corks would have been popping. But instead, the FDA handed Amgen the dreaded CRL.
What's that, you ask? CRL replaced the old approvable letters. The terminology was a bit confusing. People would see the word approvable and think, "Oh, good!" But it wasn't.
Approvable was a euphemism for delay as in, "We might approve the drug sometime down the road, if/when you dot an i or cross a t and/or provide us some more information/data."
This morning Amgen announced that the FDA wants more details on how the company will monitor patients once Prolia is on the market. And the agency requested Amgen do another study to see if Prolia works at preventing osteoporosis.
It was the second CRL to be disclosed this morning. Novartis got one, too. NVS' is for a one-a-day inhaler to treat COPD, or what some more broadly refer to as smoker's cough.
Novartis would only say that the agency wants more info on the dosing. Sometimes companies fully disclose what's contained in a CRL, sometimes they reveal some or a little bit of information and other times nothing at all. I suspect that both companies got their respective CRLs last Friday or over the weekend since both press releases hit the wires bright and early.
Biopharma companies, it seems, have gotten so used to getting an approvable letter or CRL, that they all reach into the drawer and pull out the same press release template and just fill in the blanks. For example, Amgen says it "will work with the FDA to determine the appropriate next steps...." And Novartis says it "will continue to work closely with the FDA...." I guess Novartis must have a cozier relationship with regulators than Amgen. Kidding. Kidding!
P.S. Please tune in to CNBC's "Power Lunch" at noon ET for my exclusive interview with Pfizer Chairman and CEO Jeff Kindler after the company reports earnings Tuesday morning.
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