The EMA has announced that Medday have withdrawn the licence application for high dose Biotin.
The EMA were not convinced by the data presented.
The European Medicines Agency (EMA) has been examining data on high dose biotin (MD1003, Qizenday) since the application was accepted in September 2016. 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. The company reserved the right to re-apply for licensing in the future.
Wc500240381 from BartsMSBlog
Trials are ongoing but as NDG has said “the data may have been less damning if the MRI atrophy data presented ECTRIMS had been positive”.
The problem I see for this agent is they they don’t really know how it works and this may be a fundamental problem.
The trials have been designed to show that it an agent targeting progressive disease, but based on the early reports it suggested to me that the benefit was either symptomatic or perhaps repair and so the trial design may need to be very different.
Why do I say this?
It was because the reported benefits were occurring quickly.
So could this be another instance of Death of a Drug by Trial Design-meaning perhaps the drug could work but the trial was no designed so that the drug could shine.