Boehringer Ingelheim finally has skin in the game, scoring its first dermatology FDA nod

When the subject is skin disorders, Boehringer Ingelheim isn’t the first company that comes to mind.  

But Thursday, the world’s largest privately owned pharma became the first company to score an FDA approval to treat generalized pustular psoriasis (GPP), a rare and life-threatening skin condition that causes eruptions of painful blisters. These GPP flares are so disruptive to the system that they can trigger heart failure, renal failure or sepsis.   

The nod is for BI’s antibody drug Spevigo. The IL-36 receptor inhibitor is also under review in Europe, and a decision is expected before the end of this year. It is the first dermatology approval for the German firm.

With the FDA blessing, BI beat AnaptysBio to the punch in GPP. The San Diego company also has an IL-36 drug, imsidolimab, in development, and phase 3 results are due by the end of next year.

BI also is conducting a trial of Spevigo as a maintenance treatment to prevent flares. In addition, the company is investigating its effectiveness against other skin diseases such as palmoplantar pustulosis and hidradenitis suppurativa.

Supporting the GPP approval was a phase 2 trial of 53 patients with flares. Of those treated with Spevigo, 54% were clear of their skin pustules compared to 6% for placebo. Spevigo's protection sustained for 12 weeks.

GPP is caused by an accumulation of neutrophils, a type of white blood cell, in the skin. It causes eruptions of pustules and red, inflamed skin all over the body. Because it is so rare, the condition is under-diagnosed and often mistaken for other skin disorders.

Doctors have typically treated GPP off-label with drugs such as AbbVie’s Skyrizi, Novartis’ Cosentyx, Amgen’s Enbrel, Johnson & Johnson’s Tremfya and a host of others.

“The approval of Spevigo is a turning point for dermatologists and clinicians,” Mark Lebwohl, M.D., the lead investigator and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, Kimberly and Eric J. Waldman Department of Dermatology, said in a release.