Talk about a tough audience! You know the Food and Drug Administration is becoming strict when a drug that's already approved for one indication can't expand into a second, related indication, especially when its short-acting counterpart is already approved for the indication.
That's the problem facing Johnson & Johnson (NYSE:JNJ). Last night the health-care giant announced that the FDA has asked for more information before approving its application to market Risperdal Consta for frequently relapsing bipolar disorder. The long-lasting drug is already approved to treat schizophrenia and regular Risperdal is approved to treat bipolar disorder.
Perhaps I shouldn't have been so gung-ho about the approval, but there didn't seem to be anything that would derail it. In fact, investors still don't know what the problem is. In typical large-pharma fashion, Johnson & Johnson didn't say what information the FDA wanted, although it did say that further clinical trials won't be required. Hopefully that means the delay won't be too long for Johnson & Johnson and development partner Alkermes (NASDAQ:ALKS), which gets manufacturing revenue and royalties from sales of Risperdal Consta.
Johnson & Johnson could certainly use the approval, as it lost patent protection for short-acting Risperdal last year. An approval for the longer-lasting drug could bring back some of those bipolar disorder patients and maybe even steal some from other bipolar treatments like Eli Lilly's (NYSE:LLY) Zyprexa, AstraZeneca's (NYSE:AZN) Seroquel, or Pfizer's (NYSE:PFE) Geodon.
The longer-lasting wait shouldn't be the end of the world for Johnson & Johnson or Alkermes or their investors. But that doesn't mean the two shouldn't try to get the approval wrapped up quickly, either. The sooner, the better, guys -- for you and us.
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