We are so excited to announce that yesterday the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for CoNCERT Pharmaceuticals’ CTP-543, an oral Janus Kinase (JAK) Inhibitor undergoing a clinical trial for moderate to severe Alopecia Areata. Currently, there are no drugs approved in the US or Canada for the treatment of Alopecia Areata and patients rely on the use of repurposed medications such as corticosteroids or oral immunosuppressants like Methotrexate.
Receiving the Breakthrough Therapy Designation expedites the development and review of study drugs where there is preliminary clinical evidence that the investigational drug may offer substantial improvement to the condition of interest over existing therapies. In the case of CTP-543, being granted this designation will speed up the clinical trial process. So far, the results of the clinical trial have demonstrated that patients treated with CTP-543 have shown statistically significant improvements in hair growth after 24 weeks of treatment.
With this great news, we are hopeful that the clinical trial will be successful and hopefully, CTP-543 will be one of the first drugs indicated and approved for the treatment of Alopecia Areata!
