FDA Fast Track and LBD Drugs

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FDA Fast Track and LBD Drugs

Axovant is requesting FDA Fast Track status for their experimental drug, RVT-101, for use with DLB.* This drug enhances the release of acetylcholine and has already been tested for use as an add-on treatment with Aricept for AD patients, with positive results. Axovant is presently looking for people diagnosed with DLB to participate in clinical trials. Contact them here if you are interested.

The FDA Fast Track program is a government program designed to facilitate the development, of drugs to treat serious conditions. This program can cut years off the time before a drug is ready for the market. Drugs to treat Alzheimer’s and Parkinson’s have been placed on Fast Track but so far, none to treat LBD.* RVT-101 would be the first.

Even with Fast Track, the time between the discovery of a new drug and its appearance on the market can be long. For example, Biogen’s aducanumab (BIIB037-bib-037) is a special human antibody designed to target amyloid plaques in Alzheimer’s patients. Antibodies are a part of the body’s natural garbage removal process. Researchers hope to prove that this drug safely facilitates the early removal of these plaques. The studies so far are showing this to be so. However, clinical trials have been going on since 2005. Results from Phase 3 trials, which started in 2015 aren’t in yet....i.e, it has been ten years since the first clinical trials and it is still not ready for market.

Unlike BIIB037, which attacks the cause of the problem, RVT-101 attempts to slow down a disease process that has already gotten such a head start that it cannot be stopped. While this has obvious value for those patients presently dealing with LBD, I wish we could see more focus on, and even Fast Track status, for LBD drugs such as Nilotinib (Tasigna—Tah-sig-na).

Like BIIB037, Tasigna works by improving the function of the body’s natural garbage disposal system, thus decreasing the production and spread of Lewy bodies. With intervention coming much earlier in the progression of the disease, there is hope for better results and even the possibility of an eventual cure. Because this is a cancer drug, already approved by the FDA for use with humans, the testing period is shorter. However, don’t expect it to be available for several years. Researchers are planning a double blind clinical trial to test safety and efficacy with Parkinson’s and DLB patients, to begin in 2017. Contact the Michael J Fox Foundation if you are interested in participating.

There are some concerns about Fast Tracking new drugs. Serious side effects may not be discovered before they are being used by the general public. With LBD's already serious drug issues, that could be a concern. And so, it is an ongoing conflict: We'd like to see these drugs that address the initiating problems in use as quickly as possible...but we don't want to see more drug sensitivity problems either. What do you think?

* Acronyms:
LBD: Lewy body dementia
PlwD: person living with dementia
PlwLBD: person living with LBD
DLB: dementia with Lewy bodies
PDD: Parkinson's disease with dementia
MCI: mild cognitive impairment
MCI-LB: the form of MCI that precedes LBD
BPSD: behavioral and psychological symptoms of dementia

For information about Lewy body disorders, read our books:
A Caregivers’ Guide to Lewy Body Dementia
Managing Cognitive Issues in Parkinson's and Lewy Body Dementia

Helen and James Whitworth are not doctors, lawyers or social workers. As informed caregivers, they share the information here for educational purposes only. It should never be used instead of a professional's advice.