Pharmaceutical Business review

EMA committee grants positive opinion for Abbvie’s Humira to treat hidradenitis suppurativa

Humira is designed for the treatment of these adults with an inadequate response to conventional systemic HS therapy.

HS, referred to as acne inversa, is a painful, chronic inflammatory skin disease for which there is no known cure and no approved medication.

If granted marketing authorization by the European Commission (EC), Humira will become the first and only medication approved to treat HS.

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

"If approved, Humira could offer new hope to people impacted by moderate to severe HS, and this demonstrates AbbVie’s ongoing commitment to innovation with HUMIRA to provide new solutions for difficult-to-treat diseases."

The CHMP positive opinion is based on the results of two pivotal Phase III studies, PIONEER I and PIONEER II, which showed that moderate to severe HS patients treated with Humira 40mg weekly starting at week four following 160mg at Week 0 and 80mg at week two achieved a significantly greater response versus those on placebo at 12 weeks.

The review of the HS application is being carried out under the centralized licensing procedure. The marketing authorization decision is expected from the EC in the third quarter of this year.

Following approval, the authorization will be valid in all 28 member states of the EU, as well as in Iceland, Liechtenstein and Norway.