GERMANY – Boehringer Ingelheim has officially entered the dermatological arena having been granted approval by US Food and Drug Administration (FDA) for a drug in a skin disease indication, reports industry media Fierce Pharma.

Generalized pustular psoriasis (GPP), the disease in question, is a rare and life-threatening condition where painful blisters form on the skin.

These GPP flares are so disruptive to the system that they can trigger heart failure, renal failure, or sepsis.  

The nod is for Boehringer Ingelheim’s antibody drug Spevigo.  The drug blocks the activation of the interleukin-36 receptor (IL-36R), a key part of a signaling pathway within the immune system shown to be involved in the cause of GPP.

The interleukin-36 (IL-36) receptor inhibitor is also under review in Europe, and a decision is expected before the end of this year.

With the FDA approval, Boehringer Ingelheim 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.

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.

Boehringer Ingelheim 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.

No visible pustules

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.

During the trial, the most common adverse reactions in under 5% of the patients that received Spevigo were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection.

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 underdiagnosed 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.

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