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High dose biotin withdrawn from European licensing

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Medday, the company developing high dose biotin for progressive MS, has told the European Medicines Agency that it wishes to withdraw its licence application for the treatment of progressive multiple sclerosis.

The European Medicines Agency (EMA) has been examining data on high dose biotin (MD1003, Qizenday) since the application was accepted in September 2016. At a meeting last week, the EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the clinical data from two trials that enrolled 253 patients was not sufficient to assess the effectiveness or the safety of biotin.

In its letter notifying the EMA of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP’s opinion that the clinical data was not sufficient but reserved the right to re-apply for licensing in the future.

MD1003 is a highly concentrated formulation of biotin under investigation as a treatment for secondary and primary progressive multiple sclerosis (MS). It is thought that very high doses of biotin may be effective in MS by promoting myelin repair through activation of an enzyme involved in myelin synthesis and by enhancing energy production in demyelinated nerves.

Results from a small pilot study provided initial evidence that high doses of biotin might have an impact on disability and progression. A larger clinical trial showed evidence of an improvement in disability in approximately 12% of people taking high dose biotin for 12 months.

A further clinical trial (SPI2) is currently underway and will continue to recruit participants with primary or secondary progressive MS from North America and Europe, including study centres in Edinburgh, London and Manchester. The estimated completion date for this trial is September 2019. More details of this trial can be found here.

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