PharmaLex US was recently pleased to deliver exciting news to our client in Sweden, Toleranzia AB, that their orphan drug designation request that we had collaborated on together for their experimental myasthenia gravis medication had been approved for orphan status by the FDA! Reach out and ask how we can help advance your projects with the FDA.
March 22, 2017
Toleranzia AB (“Toleranzia”) today announced that the Food and Drug Administration has granted the company’s orphan drug designation application regarding its new tolerogen, TOL2.
With the receipt of orphan drug designation for TOL2 in the US, Toleranzia considerably strengthens its position in the strategically important North American market. Previously, the company has obtained orphan drug status in both the US and Europe for the drug candidate TOL1. Granted orphan drug designation in the US provides seven years of market exclusivity for the approved drug in the US market, reduced development costs and significant help from the regulatory authorities.
CEO Charlotte Fribert comments
– The positive decision from the FDA is very pleasing. The opportunity to obtain seven years of marketing exclusivity in the US, by far our most significant market, is very important for us. Orphan drug designation also brings valuable benefits during the drug development phase, such as cost reduction and potentially a faster process to take an effective and safe myasthenia gravis treatment to the market. That fact that we now received orphan drug designation for a second tolerogen significantly strengthens our commercial position in our main indication – myasthenia gravis.
For further information, please contact:
Charlotte Fribert – CEO
Phone: +46 763 19 98 98
This information is information that Toleranzia AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication on March 22, 2017.
About the company
Toleranzia AB (556877-2866) has developed a platform technology for treatment of autoimmune diseases. The company´s main project is directed towards an autoimmune neuromuscular disease, myasthenia gravis, with a significant need for an effective treatment and an extensive market potential, for which Toleranzia has been granted Orphan Drug Designation in both EU and US. The platform technology enables development of therapies that target the root cause of the disease – not just the symptoms, which is the mainstay of current treatment. In addition to myasthenia gravis, the platform technology has been evaluated in three further disease indications – rheumatoid arthritis, multiple sclerosis and type 1 diabetes, where positive treatment effects have been obtained in disease-relevant animal models. Toleranzia was founded by researchers at the University of Gothenburg. The company has operations at the Biotech center in Gothenburg. Further reading at: www.toleranzia.com.