FDA extends review until Jan. 22, 2010

FDA delays ruling on Acorda's MS drug until Jan.

Acorda Therapeutics says FDA extends Fampridine-SR review by 3 months until Jan. 22

On 6:38 am EDT, Thursday October 22, 2009

Companies: Acorda Therapeutics, Inc.

HAWTHORNE, N.Y. (AP) -- Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months.

The agency was due to make a decision by Thursday, but the ruling is now due by Jan. 22, 2010.

Acorda said the FDA extended its review because it recently submitted new information on its risk evaluation strategy for the drug.

Acorda sent in the additional information following a meeting with an FDA panel on Oct. 14. The panel recommended that Fampridine-SR receive FDA approval.

Source:
http://finance.yahoo.com/news/FDA-delays-ruling-on-Acordas-apf-3235846838.html?x=0&.v=1

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics and manufactured by Elan Corporation plc.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders. The Company's marketed products include Zanaflex Capsules^® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

Source:
http://finance.yahoo.com/news/Acorda-Therapeutics-Reports-bw-2362944900.html?x=0&.v=1

About MS

Multiple sclerosis is a chronic, usually progressive disease in which the immune system attacks and degrades the function of nerve fibers in the brain and spinal cord. More than 400,000 Americans have MS, most between the ages of 20 and 50, with women affected two to three times more than men. Worldwide, MS may affect 2.5 million individuals.

Research indicates 64%-85% of people with MS have difficulty walking, and 70% report walking to be the most challenging aspect of their MS. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and, in later stages, up to a third of patients are unable to walk.

Source:
http://www.pmdcentral.com/Acorda-Therapeutics-Announces-Positive-Vote-by-FDA-Advisory-Committee-for-Fampridine-SR/article/152332/

Ground Breaking News -- Finally.. a pill for MS?!!?

Fampridine-SR would treat difficulty walking

On October 14, an FDA advisory committee recommended Fampridine-SR for approval. The FDA is expected to make a final decision on or before October 22 (target date about whether to approve the drug for market). The expected decision will make Fampridine-SR (with the proposed brand name Amaya) the first medication ever approved specifically to treat an MS symptom.

In phase-III clinical trials, Fampridine-SR was found to improve walking speed in people with MS. While the studies mainly measured gait improvement, some participants said they felt less disabled during their daily activities. The drug, developed by Acorda Therapeutics, works by blocking tiny potassium channels on nerve surfaces, which may temporarily enhance nerve signaling.

Filling a treatment gap
FDA approval would fill a large gap in current MS treatments, since this drug has shown benefit even in those with primary progressive MS, a form for which there are no approved disease-modifying therapies.

"Although we might think of difficulty walking as an isolated symptom of MS, this is far from true," said Nicholas LaRocca, PhD, in a statement for the committee. "It affects a large range of everyday activities." LaRocca is the vice president of Health Care Delivery and Policy Research at the Society.

While the FDA is not required to follow advisory committee recommendations, it almost always does.

Please take the time to read more on this fantastic finding, go to the following source link below at National Multiple Sclerosis Society's website to read the 10/14/09 News Detail. :) *It is not very long or a complicated read, really*

Source: National Multiple Sclerosis Society

• http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=2239

New Immune-suppressing Treatment

Multiple Sclerosis Successfully Reversed In Mice: New Immune-suppressing Treatment Forces The Disease Into Remission

ScienceDaily (Aug. 12, 2009) — A new experimental treatment for multiple sclerosis (MS) completely reverses the devastating autoimmune disorder in mice, and might work exactly the same way in humans, say researchers at the Jewish General Hospital Lady Davis Institute for Medical Research and McGill University in Montreal.

MS is an autoimmune disease in which the body's own immune response attacks the central nervous system, almost as if the body had become allergic to itself, leading to progressive physical and cognitive disability.

The new treatment, appropriately named GIFT15, puts MS into remission by suppressing the immune response. This means it might also be effective against other autoimmune disorders like Crohn's disease, lupus and arthritis, the researchers said, and could theoretically also control immune responses in organ transplant patients. Moreover, unlike earlier immune-suppressing therapies which rely on chemical pharmaceuticals, this approach is a personalized form of cellular therapy which utilizes the body's own cells to suppress immunity in a much more targeted way.

GIFT15 was discovered by a team led by Dr. Jacques Galipeau of the JGH Lady Davis Institute and McGill's Faculty of Medicine. The results were published August 9 in the prestigious journal Nature Medicine.

GIFT15 is composed of two proteins, GSM-CSF and interleukin-15, fused together artificially in the lab. Under normal circumstances, the individual proteins usually act to stimulate the immune system, but in their fused form, the equation reverses itself.

"You know those mythical animals that have the head of an eagle and the body of a lion? They're called chimeras. In a lyrical sense, that's what we've created," said Galipeau, a world-renowned expert in cell regeneration affiliated with the Segal Cancer Centre at the Jewish General and McGill's Centre for Translational Research. "GIFT15 is a new protein hormone composed of two distinct proteins, and when they're stuck together they lead to a completely unexpected biological effect."

This effect, explained Galipeau, converts B-cells -- a common form of white blood cell normally involved in immune response -- into powerful immune-suppressive cells. Unlike their better-known cousins, T-cells, naturally-occurring immune-suppressing B-cells are almost unknown in nature and the notion of using them to control immunity is very new.

"GIFT15 can take your normal, run-of-the-mill B-cells and convert them -- in a Superman or Jekyll -Hyde sort of way -- into these super-powerful B-regulatory cells," Galipeau explained. "We can do that in a petri dish. We took normal B-cells from mice, and sprinkled GIFT15 on them, which led to this Jekyll and Hyde effect.

"And when we gave them back intravenously to mice ill with multiple sclerosis, the disease went away."

MS must be caught in its earliest stages, Galipeau cautioned, and clinical studies are needed to test the treatment's efficacy and safety in humans. No significant side-effects showed up in the mice, he said, and the treatment was fully effective with a single dose.

"It's easy to collect B-cells from a patient," he added. "It's just like donating blood. We purify them in the lab, treat them with GIFT15 in a petri dish, and give them back to the patient. That's what we did in mice, and that's what we believe we could do in people. It would be very easy to take the next step, it's just a question of finding the financial resources and partnerships to make this a reality."

Source:

• http://www.sciencedaily.com/releases/2009/08/090811143725.htm

Thank you to my friend, Amanda, for alerting me to this article. This would be even better than an oral pill to eliminate the syringe administration of medicine. :) Technology and science is a surprising and every changing thing - I am always keeping my fingers crosses for good news!

Yippie - Copay change!

I had a nice surprise on Saturday (5/9) when I went and picked up my last 30-day Copaxone refill. The pharmacist scanned my Rx and told me my total was $30. With a quizzical tone I asked her "$30 is my total, that is it.. just $30?" because, if you remember, I had been paying $150 for a 30-day supply. She explained how so many people had complained to Catalyst, Beaumont's Pharmacy Benefit Manager (PBM), about the copay cost for the medications in the same tier as Copaxone that they changed the copay.

I was so thrilled that I was not the only one the complained.. and that our complaints had been heard and addressed. Not to say I don't appreciate the beneficial copay change, but I miss when I was able to get the 3 month supply for $50 before Beaumont changed insurance companies.

Say 'good-bye' to needles?!

Significant research announcements during MS Week

30 Apr 2009

This year’s MS Week is set to be one of the most memorable of awareness weeks for multiple sclerosis (MS) after a number of significant drug announcements.

Scientists specialising in MS and presenting at the annual American Academy of Neurology convention in Seattle have reported research findings that take the field of MS treatments to a “new dawn”.

Head of Research at the MS Society, Dr Lee Dunster, said: “This week’s announcements herald a step change in treatment options for people with the most prevalent form of MS at the time of diagnosis.

“News of the development of two oral therapies for MS marks a new dawn and this could be a huge step forward for people who currently have to inject their treatments.

“We are looking at treatments that could be available on the NHS by the end of next year that will make a real difference to people’s lives.”

Today (Thursday), Professor Gavin Giovannoni from Queen Mary, University of London announced trial results of the drug cladribine, which may become the first effective treatment available in tablet form for relapsing remitting MS.

The Merck Serono drug, used in leukaemia for a number of years, was shown in latest studies in more than 1,300 people to bring about a 58 per cent reduction in yearly relapse rates compared to placebo.

There was also a 30 per cent reduction in progression of disability as measured by the Expanded Disability Status Scale (EDSS) and a reduction in lesion activity (as measured by MRI) in participants taking up to 30 cladribine tablets over the two years.

Meanwhile, Novartis announced news yesterday (Wednesday) of the latest results of their oral MS therapy, FTY720 (fingolimod).

The Phase III results showed that in more than 1,200 people with relapsing remitting MS the drug brought about a 52 per cent reduction in yearly relapse rates compared to beta interferon.

The treatment has yet, however, to show potential to slow progression of disability.

Source:

• http://www.mssociety.org.uk/go.rm?id=25858

December '08 Test Results

I wanted to post a quick follow-up to my last posting.

As I assumed, Casey was able to translate my lab results from all the blood drawn back in December. Everything is fine and in the 'optimal' range :)