The FDA May Move Quickly on Exelon

If you happen to be visiting our site for the first time today, you may get the impression that all we write about are Parkinson’s drugs. That is not the case. We spend plenty of time talking about living well, issues to help caregivers, other treatment options, and events in the Parkinson’s community. It’s just that yesterday was a pretty good day for the PD community. By happenstance, we got good news about two new drugs that will help a significant proportion of people with Parkinson’s. Let’s celebrate this accomplishment, and consider these positive steps forward. Nevertheless, there is still a lot of work to do. First, the FDA issued an approval to the makers of AZILECT®, which appears to be a promising drug. Click here to review yesterday’s blog about Azilect. It feels very good to report something that many people can use in the very near future. Also, in a blog from yesterday we mentioned that the FDA was considering approving Exelon for PD. Exelon is already on the market to treat dementia in Alzheimer’s. That meeting concluded yesterday with the panel of seven outside, expert panelists recommending unanimously that the FDA approve Exelon for mild to moderate dementia in PD. The FDA does not have to follow the recommendation, but it does have a history of doing so. The next big question is, how long will it take the FDA to decide. Regardless of the time, some doctors may begin to prescribe it immediately. Click here to read a Reuter’s article about the meeting. The meeting was controversial. Some attended to urge the FDA against approving Exelon. They argued that it had only been through one study to measure its effectiveness in people with Parkinson’s. Most drugs must go through at least two. Furthermore, some physicians and scientists were concerned that the differences between Alzheimer’s dementia and the dementia associated with PD was not well-defined.

Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, accused Novartis of "disease mongering" by inventing a new ailment to boost drug sales. He said most new FDA approvals require two supporting studies, but Novartis had only performed one. He also said the company had not shown that symptom improvement actually improved the lives of patients or their caregivers.

Dr. Lurie’s point is well founded because this approval is much hastier than most. However, there is a very significant need for a medication for PD related dementia. Moreoverver, we have some reasonably good safety data from before and after Exelon was approved for Alzheimer’s. There could still be risk. Furthermore, I have to ask how tough life can be for a person with Parkinson’s, their caregiver(s), and others who care about them, when they have dementia. I am thrilled for PWPs that can derive a benefit from Azilect or Exelon. Nevertheless, we hope to see more breakthroughs in the near futurep and, that our steps approach a cure at an ever-increasing rate.