Medday, the makers of Biotin have formally withdrawn their application for EMA (European Medicines Agency) marketing authorisation for progressive MS drug Qizenday.
Qizenday is a capsule medicine that contains the active substance biotin and is taken orally. The drug was to be used to treat adults with the progressive form of multiple sclerosis (MS).
How the drug works is not well understood; however, it is thought that the medicine acts on enzymes (known as carboxylases) to increase energy production in the damaged nerves and helps to repair the protective sheath around the nerve cells.
Three of these enzymes are involved in energy production, while a fourth is believed to be involved in the production of sheaths around the nerve cells.
In the letter Medday sent to the EMA, notifying it of the withdrawal, the company stated that the decision was based on the CHMP’s (The Committee for Medicinal Products for Human Use) opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.
A small pilot study provided evidence that a high dose of biotin could have an impact on disability and progression in MS patient. A larger clinical trial then provided further results of disability improvement in patients taking a high dose of biotin over a 12 month period.
Dr Frederic Sedel, co-founder and CEO of Medday said: “The decision to withdraw the application was based on the understanding that the EMA was not ready to approve high dose biotin for the treatment of progressive MS based on a single –relatively small- phase III study. This decision means that we will present a much stronger case in the future, based on the results of the ongoing SPI2 study, which is a much larger trial. The SPI2 trial is still looking at patients’ improvement together with decreased progression which is a very ambitious goal. It will also give more information about the subgroups of patients who will benefit the most from the drug, about brain imaging and other measures of efficacy.”
The SPI2 trial is being conducted with primary and secondary MS patients from North America and Europe, which includes study centres in Edinburgh, London and Manchester. The trial is still recruiting and is looking to have reached completion by September 2019.