Incyte Reports EMA’s Validation of MAA for Ruxolitinib Cream to Treat Vitiligo

October 29, 2021 Auto Bot EMA, Incyte, MAA, regulatory, vitiligo 0

Shots:

  • The MAA is based on the P-III TRuE-V clinical program that consists of 2 P-III studies ie., TRuE-V1 & V2 evaluating ruxolitinib cream in 600+ patients aged ≥12yrs. with vitiligo
  • The therapy demonstrated improvements in facial & total body repigmentation @ 24wks. of treatment, patients treated with ruxolitinib cream did not report site reactions while the overall safety profile was consistent with previous study data
  • With the validation, the submission is complete & the EMA will now initiate the review procedure. In Sept’21, ruxolitinib cream has received the US FDA’s approval for chronic treatment of mild to moderate AD in non-immunocompromised patients aged 12yrs.

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