Boehringer Ingelheim announces European Medicines Agency’s filing acceptance and validation of marketing authorization application for spesolimab in generalized pustular psoriasis

• The marketing authorization application (MAA) package includes results from the pivotal Effisayil-1 global trial

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim announced today that the company’s marketing authorization application (MAA) for the treatment of flares in generalized pustular psoriasis (GPP), has been validated and is now under evaluation with the European Medicines Agency (EMA).

“GPP is a rare, life-threatening neutrophilic skin disease characterized by painful, sterile pus-filled blisters, that can suddenly appear over the body,” said Dr. Janine Lamar, Global Spesolimab Lead at Boehringer Ingelheim. “Despite its name, GPP is very different to the more common plaque psoriasis. With no approved treatments in the EU for GPP flares, acceptance of the application for review of spesolimab brings us one step closer to providing a targeted treatment for people with this distressing, unpredictable and painful skin condition.”

GPP is characterized by episodes of widespread eruptions of painful, sterile pustules (blisters of non-infectious pus).^1,2,3 The inflammation can also affect other parts of the body and can lead to infections or other organ complications that may be life-threatening.

There is a high unmet need for treatments that can rapidly and completely resolve the symptoms of GPP flares. Flares greatly affect a person’s quality of life⁴ and can lead to hospitalization with life-threatening complications, such as heart failure, renal failure, sepsis and even death.⁵

The marketing authorization application was based on the 12 week Effisayil-1 trial; a multi-center, double-blind, randomized, placebo-controlled trial that evaluated efficacy, safety, and tolerability of spesolimab (single dose 900 mg spesolimab i.v., with the option of a 2nd dose if symptoms persisted on Day 8) in patients experiencing a GPP flare.⁶ The study demonstrated superiority over placebo in pustular clearance after one week of treatment.

Please click on the following link for ‘Notes to Editors’:

http://www.boehringer-ingelheim.com/press-release/ema-filing-acceptance-and-validation-spesolimab