Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for spesolimab (SPEVIGO) to prevent generalised pustular psoriasis (GPP) flares.

The antibody received the designation as an investigational treatment to prevent flares in adolescents and adults. 

The Center for Drug Evaluation of China’s National Medical Products Administration has also awarded a BTD to spesolimab.

Boehringer Ingelheim managing directors board member and human pharma head Carinne Brouillon stated: “GPP flares may appear suddenly, intensify quickly, and can be life-threatening if left untreated, leaving those affected feeling anxious and uncertain about their future.

“The FDA’s recognition of the urgent need for preventing GPP flares is a major step towards empowering people living with the condition to plan critical moments in their lives, despite their disease.”

Both designations were granted based on topline data from the EFFISAYIL 2 trial that examined whether long-term treatment with spesolimab helps to prevent the flares in adolescents as well as adults with GPP for up to 48 weeks.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Safety data were found to be consistent with earlier clinical trials.

Spesolimab is a humanised selective antibody that blocks interleukin-36 receptor (IL-36R) activation.

It has now gained approval from regulatory authorities in 40 countries, including Japan, the US and mainland China, as well as the European Union.

In April 2023, Boehringer Ingelheim and Swiss company RetinAI Medical collaborated to leverage artificial intelligence to advance novel treatments for geographic atrophy patients.