The approval was based on data from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 trials, which included adults with severe alopecia areata.
The THRIVE-AA1 trial included adults aged 18 to 65 years with moderate to severe alopecia areata who had at least 50% scalp hair loss.
Improvement in lesional scalp transcriptome toward nonlesional profile seen at week 24 for both ritlecitinib, brepocitinib
However, many patients experience improvements in hair density with standard alopecia treatments
Results from 2 studies show statistically significant improvement in scalp hair regrowth with baricitinib, a JAK inhibitor.
Both doses of baricitinib met the primary end point, demonstrating statistically significant improvement in scalp hair regrowth compared with placebo.
Younger patients and those with alopecia have significant disproportionality signals for increased suicidality
The FDA has granted Breakthrough Therapy designation to CTP-543 (Concert Pharmaceuticals), an oral Janus kinase (JAK) inhibitor for alopecia areata.
The FDA has granted Breakthrough Therapy designation to baricitinib (LY3009104; Lilly), an oral Janus Kinase (JAK) inhibitor, for the treatment of alopecia areata.