Top Boehringer Ingelheim drug gets FDA approval in rare skin disease

For many patients with generalized pustular psoriasis (GPP), the journey to diagnosis could take years, as doctors can mistake the incredibly rare skin condition for an infection. And when they do get diagnosed, there are only a few drugs — none officially approved — they can use to manage the painful flares that characterize the disease.

Boehringer Ingelheim just got the green light to change that for US patients.

The FDA has approved spesolimab, an IL-36R antibody, to treat GPP flares in adults. It will be marketed as Spevigo.

The German pharma emphasized in its release how the autoimmune disease can lead to life-threatening complications, such as heart failure, renal failure and sepsis.

Carinne Brouillon

“We recognize how devastating this rare skin disease can be for patients, their families and caregivers,” Carinne Brouillon, a member of Boehringer’s board of managing directors responsible for human pharma, said in a statement.

In a pivotal Phase II trial, slightly more than half of the patients — most of whom started with a high density of pustules on their body and impaired quality of life — showed no more visible pustules after 12 weeks of spesolimab.

The OK gives Boehringer a significant lead over AnaptysBio, which is developing a similar IL-36R antibody for the same indication, and could affect AnaptysBio’s recently revealed plans to out-license the drug.

Both companies, though, have been running into setbacks trying to test their drugs for other diseases. While Boehringer once touted spesolimab as a top program, just a few weeks ago it quietly shut down a small Phase II study in Crohn’s patients suffering from bowel obstructions, citing the current therapeutic landscape.

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