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Home Industry News AbbVie’s Humira recommended for new skin disease approval

AbbVie’s Humira recommended for new skin disease approval

29th June 2015

AbbVie has announced that its multipurpose drug Humira has been recommended for European approval as a treatment for hidradenitis suppurativa.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for Humira to be approved for the treatment of active moderate to severe hidradenitis suppurativa in adult patients with an inadequate response to conventional therapy.

Also known as acne inversa, this painful, chronic inflammatory skin disease estimated to impact around one percent of the adult population worldwide, and there are no approved therapies for this condition in the EU.

Data from two phase III studies, PIONEER I and PIONEER IIm have demonstrated the safety and efficacy of the drug.

Dr Michael Severino, executive vice-president for research and development and chief scientific officer at AbbVie, said: "The positive opinion from the CHMP is a significant milestone for people with hidradenitis suppurativa in Europe, because it represents progress toward the first and only approved medicine for this devastating disease."

Humira was first made available 12 years ago and is now used to treat more than 850,000 patients across 12 indications worldwide.ADNFCR-8000103-ID-801792623-ADNFCR

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