More hope, more questions.
How soon will the new drugs
be available for doctors to
We hope it will be soon, but first, the two drug companies must assemble their data, complete analyses, and submit applications for approval to market in the U.S. The Food and Drug Administration then conducts professional reviews which can take a year or more. As soon as a favorable recommendation is made about either drug, the National MS Society will press for speedy final approval.
In the meantime, Copaxone (copolymer I) is available through an FDA-approved program called a Treatment IND for limited numbers of people in designated medical centers around the country. Your local chapter or our national Information Center have specific information. Call 1-800-FIGHT-MS. Or, call TEVA at 1-800-840-5601. Biogen's interferon is not currently available.
Which drug is best?
The new agents weren't tested against each other or against Betaseron. People in all three studies had different MS profiles - that is, they had different degrees of disability and number of years with MS; moreover, the studies were designed differently. Thus the sets of data cannot be compared properly.
At this point, there is no way to know if a person who has done poorly with Betaseron would benefit from the Biogen agent or Copaxone, or if Copaxone would be appropriate for use with either of the other two.
How much will these drugs
They are expected to be expensive. Like Betaseron, both require complex manufacturing methods. However, neither drug company has issued a statement on prices.
How do the side effects
Side effects are hard to compare if they aren't balanced against the treatment benefit and the treatment benefit can't be compared using facts from the three studies, as explained above. However, it's realistic to remember that virtually all drugs produce some side effects in some individuals.
Are results of the new
Biogen or Copaxone studies
No, but data from both trials are expected to appear soon in professional journals, allowing a wider review by the community of MS experts.
What is known about the long-term
effects of these agents?
The first people with MS to take Betaseron were volunteers in a pilot study beginning in 1988. Pilot studies of Copaxone began in the late 1970s, and Biogen's interferon beta-1a was first taken by people with MS in the mid-1980s.
Long-term safety is always a concern; thus makers of all new FDA-approved agents are required to monitor reports of side effects. Trials and review periods are designed to help ensure safety, though the time they take can try the patience of those who are waiting for help. On the other hand, making useful new drugs available quickly requires accepting some unknowns, especially for drugs that may be taken for a lifetime.
Is there anything on the
horizon that doesn't require
Some oral agents are among the scores of therapies now in clinical trials, including a pill called Myloral, produced by AutoImmune, Inc. This pill contains a cow myelin preparation, which may affect MS through "oral tolerization".
Currently neither Betaseron, Copaxone, nor the new beta interferon from Biogen can be taken in pill form. MS specialists and the pharmaceutical companies are looking into developing and testing injector systems that can deliver drugs under the skin or into the muscle without a needle stick.
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|Title Annotation:||information on new multiple sclerosis drugs|
|Date:||Jan 1, 1995|
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