Biotin for multiple sclerosis: a new clinical trial and hopes that this year will be authorized in Europe.
Previous trials have found that biotin for progressive multiple sclerosis may slow, even modestly reverse the progress of disability. The drug is already approved in France and can reach the entire European market by the end of this year.
MD1003 is a drug developed by the French company MedDay that contains biotin in very high doses, as much as 10,000 times more than the recommended daily intake dose.
Biotin is an essential vitamin for carrying out many biochemical processes that lead to the production of fatty acids and the use of energy by the cell. The two properties above are those that are supposed to be based on the benefits of biotin for multiple sclerosis.
On the one hand, it helps repair myelin-the substance that is lost in people with MS- and on the other hand it contributes to the survival of neurons by increasing energy production.
You may also be interested in reading: Neurodegeneration in multiple sclerosis.
Biotin as a treatment for multiple sclerosis. Against neurodegeneration, not inflammation.
MedDay's biotin formulation has something special: it is geared toward the treatment of progressive forms of MS, something that is rare until the recent release of Ocrevus into the US market for the treatment of progressive primary multiple sclerosis.
And it is that MD1003 has no effect on inflammation, that is, it will not help prevent new outbreaks, but rather it seeks to reverse and slow down the progress of neurodegeneration , one of the primary causes of disability in people with MS.
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What has been found so far?
Biotin for multiple sclerosis
In 2016 the Multiple Sclerosis magazine published the results of a clinical trial that evaluated the efficacy of the 100 mg dose of biotin administered 3 times a day in 154 patients, some of them received MD1003 and others a placebo compound.
The analysis of results showed that 12.6% of those treated with biotin experienced improvements in two tests that measure disability in people with MS. This did not happen in any of those who received the placebo.
Although 12.6% may seem like a low figure, we must bear in mind that the simple fact of not experiencing deterioration, or doing it at a slower pace, is already good news. Improve qualifies as excellent.
In the rest of those who took biotin, although the results were not as marked, benefits were also reported.
According to the CEO of MedDay, Dr. Frédéric Sedel, to the magazine Multiple Sclerosis News Today, the effect of biotin is not seen immediately , but it becomes evident as the months go by, 9 to where they have suggested clinical trials
You may also be interested in reading: Lassitude: extreme fatigue in multiple sclerosis. Manifestations, causes and treatments.
The new clinical trial with biotin for multiple sclerosis.
This new trial responds to a requirement of the US FDA. It will be developed in 70 locations in cities in the US and Europe. We are recruiting at this time interested in participating ; They intend to reach the figure of 600 people with progressive multiple sclerosis.
There is an important criterion when choosing the participants: they should not have experienced any outbreak in the last 2 years , that is, have not active Em.
It is a logical criterion, since MedDay seeks to evaluate the effect of biotin on disability mediated by neurodegeneration. People with active MS could possibly deteriorate more acutely, preventing the true extent of the drug from being seen.
The trial will last 15 months, but in Europe we may not have to wait so long to see authorized MD1003.
Biotin for MS in Europe.
As we already mentioned, in France the drug has been authorized in a special way and about 5000 people with progressive MS have been treated .
The pharmaceutical company is already in talks with the European Medicines Agency (EMA) to obtain the authorization of the drug throughout the European territory and await the verdict by the end of this year.
It must be borne in mind that the over-the-counter biotin that is marketed contains quantities much lower than those of MD1003, which will be subject to medical prescription.
You may also be interested in reading: Primary progressive multiple sclerosis: symptoms, differentiation and treatment.