The US Food and Drug Administration (FDA) has granted approval for Boehringer Ingelheim’s SPEVIGO injection to treat generalised pustular psoriasis (GPP).

The treatment is indicated for use in adult and paediatric patients 12 years and above with a minimum weight of 40kg.

This development follows a similar approval by the Chinese National Medical Products Administration for reducing GGP occurrence in patients of the same age group.

A humanised selective IgG1 antibody, SPEVIGO attaches to the interleukin-36 receptor, which plays a crucial role in the immune system’s signalling pathway and is implicated in the pathogenesis of GPP.

The FDA’s decision was largely based on the positive outcomes of the EFFISAYIL 2 clinical trial.

The 48-week study, involving 123 patients, demonstrated that SPEVIGO significantly reduced GPP flare risk by 84% versus placebo.

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.

Remarkably, after week four, no flares were observed in the high-dose SPEVIGO group.

However, the trial also reported an increased incidence of certain adverse events associated with SPEVIGO treatment.

These included reaction at the injection site, urinary tract infection, arthralgia, and pruritus, occurring at a rate of at least nine cases per 100 patient-years compared to the placebo arm.

Boehringer Ingelheim Human Pharma head Carinne Brouillon said: “SPEVIGO’s new approvals constitute a fundamental change for people living with GPP, addressing their huge need for acute and chronic treatment.

“Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode. Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.”

This month, Boehringer signed a global collaboration and exclusive option-to-license agreement with Sosei Heptares for the development of a new class of therapies for all schizophrenia symptoms.

Under the deal, the companies will develop and market a portfolio comprising G protein-coupled receptor 52 agonists from Sosei Heptares to treat positive, negative, and cognitive symptoms linked to schizophrenia.