A potentially ground-breaking drug that could delay the onset of type 1 diabetes has been awarded the Priority Medicines (PRIME) designation by the European Medicines Agency (EMA).
The PRIME designation by the EMA is to help the drug be prioritised, such as by benefitting from an accelerated evaluation and review process.
The drug, currently known as PRV-031 (teplizumab), has been developed by Provention Bio. The drug works by attaching itself to the pro-inflammatory T cell co-receptor CD3, which in turn prevents them from activating the T cells that attack and kill the pancreas’ beta cells.
In a phase 2 clinical trial featuring 76 patients at risk of developing type 1 diabetes, the drug showed a significant slowing down in the onset and diagnosis of the condition. There was a median delay of two years reported with use of the drug compared to placebo.
The drug has had mixed results in previous trials. In 2010, the drug failed to achieve strong enough results within a phase 3 one-year trial. In 2013, however, the medication showed more promising results in a two-year trial.
Ashleigh Palmer, chief executive of Provention Bio, said: “We are very pleased the EMA recognises the transformative potential of PRV-031 and has granted this groundbreaking therapy PRIME designation.
“Following on the heels of Breakthrough Therapy Designation from the FDA in August, an EMA PRIME further validates the rationale for PRV-031 to prevent or delay the onset of clinical [type 1 diabetes] in at-risk subjects.
“We are committed to working closely with both regulatory agencies to bring PRV-031, as quickly as possible, to the many thousands of [type 1 diabetes] at-risk individuals who currently have no options to prevent or delay this catastrophic disease.”