Return of MS Drug

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FDA Allows Return of MS Drug

By Reinberg

HealthDay Reporter 1 hour, 26 minutes ago

MONDAY, June 5 (HealthDay News) -- Setting strict

guidelines as a condition, the U.S. Food and Drug

Administration said Monday that it will allow the

return of the multiple sclerosis drug Tysabri.

Tysabri (natalizumab) had received FDA approval in

November 2004, only to be pulled from the market three

months later after several patients in clinical trials

developed a rare but deadly viral infection of the

brain called progressive multifocal

leukoencephalopathy (PML).

" This is one of the very rare cases in which a drug

withdrawn from the market for safety reasons has been

returned back to the market after appropriate steps

have been taken, " Dr. K. Galson, director of

the FDA's Center for Drug Evaluation and Research,

said at a press conference.

" In this case, we made the assessment that the

benefits of this drug outweigh the risks for MS, "

Galson added. " We are certain that patients are

willing to take this risk because of the potential

benefits of the drug. "

According to the new guidelines, Tysabri can only be

administered by approved doctors, infusion sites and

pharmacies that register and comply with a

patient-safety program designed by Biogen-IDEC, the

maker of Tysabri, and approved by the FDA.

Multiple sclerosis, which affects some 350,000

Americans, is an unpredictable disease of the central

nervous system. Most MS patients experience muscle

weakness in their extremities and difficulty with

coordination and balance. Symptoms may be severe

enough to impair walking or even standing. Its cause

is not known and there is no cure, according to the

National Institutes of Health.

Studies have found that treatment with Tysabri reduced

the rate of relapse in MS patients by as much as

two-thirds after two years, and reduced the number of

patients whose symptoms worsened.

" Tysabri is a monoclonal antibody used as a single

drug for the treatment of patients with relapsing

forms of MS, " Galson said. " The drug has been used

effectively in patients who have not responded well

to, or cannot tolerate, other MS treatments. "

The drug was first approved by the FDA in November

2004, but was taken off the market by Biogen-IDEC in

February 2005. The recall occurred after three

patients in clinical trials developed PML.

The FDA put the clinical trials on hold in February

2005, but allowed them to resume in February 2006,

with no additional cases of PML reported.

With the drug's return to the market, there will

undoubtedly be other cases of PML and deaths, said Dr.

Katz, of the FDA's Center for Drug Evaluation

and Research. " This is balanced against the

significant benefit the drug confers, " he added.

" Currently, the best estimate we have of the rate of

occurrence of PLM is about one in 1,000 patients

treated, " Katz said. " We know little about what the

risk would be in a larger population or what the risk

would be if treatment continues beyond two years, " he

said.

In March, the FDA's advisory committee on drugs for

peripheral and central nervous systems recommended

reintroducing the drug with a risk-minimization

program, including mandatory patient registration and

periodic follow-up.

Tysabri will only be available through a

risk-management plan, called the TOUCH Prescribing

Program. To receive Tysabri, patients must confer with

their doctor and understand the risks and benefits of

the drug and agree to all of the instructions in the

program.

Some of those restrictions include: only those

registered with the program and who agree to comply

with it will be able to prescribe the drug; only

infusion centers registered and authorized will be

able to administer Tysabri intraveneously; only

pharmacies registered with the program will be able to

dispense Tysabri to authorized infusion centers; only

patients enrolled in the program and who agree to

comply with it will be able to receive the drug.

Finally, all program prescribers, pharmacies, infusion

centers, and patients will be educated about the

program and the risks of Tysabri.

In addition, safety surveillance -- including regular

MRIs, monitoring and reporting of PML infections and

other serious infections and deaths, and systematic

tracking of patients and drug disposition -- will be

carried out, according to the FDA.

Dr. O'Looney, director of biomedical research

at the National Multiple Sclerosis Society, agrees

with the new FDA guidelines.

" We are very pleased with the review and the outcome

from the FDA, " O'Looney said. " It's good news for

people with MS. It's good news because it provides an

option for treatment. "

O'Looney said the FDA restrictions are warranted. " We

don't know enough about the drug. The results from the

two-year study were remarkable in terms of its impact

on disease activity and progression, but there is a

concern about PML. So all of these restrictions are

justified, " she said. " It's all for the protection of

the patient. "

" The important thing is to have the drug back on the

market, so that patients and doctors can discuss

whether or not to use the drug for a particular

patient, " O'Looney said.

The National Multiple Sclerosis Society can tell you

more about multiple sclerosis.

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