Application for high dose biotin (MD1003, Qizenday) withdrawn from European Market
I found this article that in December of 2017, the application for high dose biotin has been withdrawn from the European market. https://www.mstrust.org.uk/news/news-about-ms/high-dose-biotin-withdrawn-european-licensing
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 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.
The clinical trial for SP12 is still being conducted. https://clinicaltrials.gov/ct2/show/study/NCT02936037
I have to say I found this completely confusing. It talks about how it was withdrawn yet it shows in a clinical trial the name MD1003, SP12…I’m a little unsure if there was one drug that they were trying to put to the market under one name and a similar drug that they’re still working on. That’s how it looks to me, and I’ve been looking at this for over an hour.
The clinical trial under the SP 12 is not only in Europe it’s also North America. Under my own conclusion I believe that the SP 12 is still high does biotin under a different study.