FDA Accepts Ampligen for Review
On July 8th Ampligen’s NDA was accepted for review by the FDA.
So what exactly does that mean, and how much further in the process toward approval is it?
“NDA” stands for new drug application.
This means that all three phases of the clinical trials have been completed and all of the data has been accepted by the FDA. After an NDA is completed it will take an average of 10-12 months for the FDA to review the data and give a decision on whether to approve or deny it.
There is still a little while till the FDA is going to decide, but in the long life cycle of a new drug, it is very close. This drug was first created in the 1960’s and has been in clinical trials since 1988.
For the manufacturer of Ampligen this will be huge, because if approved it will be the first and only drug for treatment of chronic fatigue syndrome.
Also another question ive been researching is, how well does ampligen work?
Here is a diary of a woman named Mary Shweitzer that has been on Ampligen for 8 years now and it seems like she has had great improvements. She stopped using it in 2006 and had a terrible relapse 1 year later after returning to a normal life. She then resumed the drug after her relapse. In here 1st few years taking it, it cost her $40,000 per year. As of 2002 it cost her $20,000 per year, which is still extremely expensive.
But if this drug is approved, then insurance may be forced to cover the expenses.
Mary had an active HHV6 infection that returned when she went off of ampligen. So, there was a viral aspect to her illness. This means that ampligen may not help all chronic fatigue patients. There seems to be many different subgroups to this illness, some which may not involve viral infection.
Ampligen is believed to work by down regulating a immune pathway (2-5 Synthetase/RNase L) that allows the immune system to better fight infection.
In a study by Dr. Richard Podell, Ampligen was shown to increase performance on a treadmill by 22% after 40 weeks of treatment. Ampligen was also tolerated very well by his patients and there were no serious side effects reported.
