Weekend Approvable Letters

J0385349Sometimes the FDA sends action letters to companies late on Friday.  When it is an approval letter, that can be unfortunate, as companies have the unenviable task of either holding the news until Monday or announcing it to a lackluster news cycle on Saturday.  However, it may have happened this week on two approvable letters, both announced on the unusual day of Saturday.  Shire and Roche both received approvable letters on investigational products and both sent the news out on Saturday:

  • Shire Receives Approvable Letter for ADHD Drug – The NDA for SPD465 was answered by an approvable letter from the FDA.  SPD465 is an investigational oral stimulant intended to provide 16 hours of treatment with one dose.  The press release gave no indication of the contents of the letter and said that Shire is evaluating its options. 
  • Roche Gets An Approvable on MIRCERA – While not stating the contents of the approvable letter, a release about it referred to label issues expected to be resolved after the Cardiovascular and Renal Drugs Advisory Committee has issued recommendations on the entire class (erthropoiesis-stimulating agents).    MIRCERA is intended for the treatment of anemia associated with chronic renal failure, including patients on dialysis and not on dialysis.  This issues associated with this class has been getting a lot of ink of late, with attention from CMS and the Hill. 

As you will remember, an approvable letter is sent by the FDA when it has deemed that the investigational compound does not yet merit approval due to circumstances the agency discloses to the company.  The company has discretion about what it will say about the contents of an approvable letter, if anything is said at all.  The issue or issues can be related to further clinical studies, label clarification or re-cutting data, to name a few.  To learn more about approvable letters, see the past posting – What Does Approvable Mean?

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