The pivotal phase 3 trials enrolled 1223 adults in the United States, Canada, and Europe.
The US Food and Drug Administration has approved the oral Janus kinase inhibitor deuruxolitinib for the treatment of adults with severefrom the drug's manufacturer Sun Pharma, is based on data from two pivotal randomized, double-blind, placebo-controlled phase 3 clinical trials :, which included 1223 adults with severe alopecia areata enrolled at sites in the United States, Canada, and Europe.
Deuruxolitinib, which comes in 8-mg tablets, is an oral selective inhibitor of JAK1 and JAK2 and is administered twice a day. According to the company press release, the average patient enrolled in the clinical trials had only 13% of their scalp hair coverage at baseline. At week 24, more than 30% of patients taking deuruxolitinib experiencing 80% or more scalp hair coverage . Also, up to 25% of patients had almost all of their scalp hair back at 24 weeks .
In terms of safety, the data showed that 3.1% of patients who received deuruxolitinib 8 mg twice daily in the phase 2 dose-ranging study and phase 3 randomized placebo-controlled trials discontinued treatment owing to adverse reactions. The three most common adverse events in placebo-controlled trials were, and nasopharyngitis . More than 100 people continued taking deuruxolitinib for more than 3 years.
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