Plegridy - the Latest FDA Approved Disease Modifying Therapy
The FDA announced on August 15, they have given approval to Plegridy for use in the United States for treatment of Multiple Sclerosis. Plegridy becomes the 11th drug approved by the FDA for use in the US. Plegridy was approved one month earlier by the European Commission for use in 28 European countries.
This disease modifying therapy (DMT) is made by Biogen Idec, and is a peginterferon beta-1a drug. It is an injectable drug, but instead of being given once a week like Avonex, Biogen Idec’s other interferon drug, Plegridy will be injected every two weeks. There is also a difference that Avonex is given intramuscularly whereas Plegridy can be injected subcutaneously (just under the skin). Plegridy has the same active ingredient as Avonex but has had a polymer called polyethylene glycol (peg) added to it that allows it to remain in the body for a longer period of time, hence reducing the frequency of the injections. Biogen Idec releases say they expect the cost of Plegridy to be about the same as Avonex, which is around $59,000 per year.
Among the side effects of interferons can be flu-like symptoms that can make the person feel miserable for a day or more after they have done the injection. Being able to spread those injections further apart with Plegridy will mean fewer days of feeling poorly and can affect many things in the user’s quality of life. You can find additional information about dosing and side effects at the National Multiple Sclerosis Society’s (NMSS) Plegridy news page.
Interferons have been in the lineup of drugs since the introduction of Betaseron (Interferon-beta-1b) as the very first MS drug approved in 1993. Since that time there have been a number of other types of drugs also approved for use, but interferons continue to be represented in the mix. You might wonder why we need all these MS disease modifying therapies- isn’t there one that proves in studies to be better than the others? The answer, quite simply. is no. There is great interest in biomarkers, those things in our bodies that make us receptive to one of these drugs more than others. Many people with MS get lucky and are on a DMT from the beginning that works well in keeping the advancement of MS at bay but others may have to try more than one DMT before finding the one their body responds to best.
Biogen Idec now has Avonex, Tysabri, Tecfidera and Plegridy on the US market as MS drugs to treat disease progression; this gives them a definite advantage in the market share of MS drugs. The other companies with more than one approved MS drug are Novartis, with their DMT’s Extavia and Gilenya, and EMD Serono with Rebif and Novantrone.
The other approved disease modifying therapy (DMT) drugs and their manufacturers are:
Betaseron, Bayer Health
Copaxone, Teva Pharmaceutical
The options of drugs and flexibility in treatment of multiple sclerosis, from oral pills to injections and infusions, continues to expand and there are many more treatments in the pipeline from other pharmaceutical companies that can’t be far behind in looking for their own approval. We are fortunate to be in a time when there are so many treatments available – 1993 wasn’t so long ago when there was great excitement at the arrival of our first MS DMT, and now we have eleven choices, with the approval of Plegridy.
Wishing you well,
NOTE: this is a corrected version, which updates the information that Immunex no longer controls Novantrone and that it is part of EMD Serono's portfolio.
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