Teva Pharmaceutical Industries ($TEVA) may have to go back to the drawing board to broaden use of its Parkinson's disease drug Azilect. An FDA advisory panel was uninspired by Azilect's ability to slow down progress of the neurological disease, just as agency staff reviewers were last week. The FDA has the final say, but it typically follows the advice of its advisory panels.
Azilect is already approved to treat Parkinson's symptoms, such as trembling, poor balance and stiffness. The new study data, designed to show the drug could slow Parkinson's advance, didn't make a convincing case that Azilect did any more than mask those symptoms, panelists said.
One panelist suggested that the first drug approved to slow down Parkinson's would have to clear a high bar. "This is really going to be the flagship ... and we have to be very solid in this and set a very high standard," panelist Robert Clancy, a neurologist at Children's Hospital of Philadelphia, said during the meeting (as quoted by Reuters). "And this is close, but it's not good enough."
Patient groups weren't persuaded, either. As MedPage Today reports, 6 advocacy organizations said evidence of Azilect's ability to slow the disease "are not yet definitive." The bottom line: Patients want to make sure a drug marketed for that use actually works. As Dr. Russell Katz, head of the FDA's neurology products division, told the panel, "If you tell people in labeling that a drug has effect on disease progression, you want to be sure that it does indeed have an effect on disease progression."
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