SPEVIGO® (spesolimab) wins 2023 Prix Galien USA Best Orphan/Rare Diseases Solution Award

Ingelheim Germany, 27 October 2023 – Boehringer Ingelheim today announced that SPEVIGO^® (spesolimab) has been recognized as Best Orphan/Rare Diseases Solution of 2023 by the Galien Foundation. The Prix Galien USA Award was presented last night in New York.

Prix Galien Foundation fosters, recognizes and rewards excellence in scientific innovation to improve the state of human health. In 2022 the U.S. Food and Drug Administration approved spesolimab as a treatment option for GPP flares in adults and the European Medicine Agency granted a conditional market authorization as first-in-class treatment option for GPP flares in adults.

“Being nominated and winning the Prix Galien for SPEVIGO^® is a testament to the exceptional work of our research and development teams to bring the first targeted and highly effective immunomodulatory biologic to people living with generalized pustular psoriasis (GPP). We are honored to be recognized among the best of the best in the pharmaceutical industry,” said Michel Pairet, member of the Board of Managing Directors and Head of the Innovation Unit. “Our scientists have achieved deep biological insights into GPP uncovering the key pathway driving the disease and based on this developed the first specific treatment for GPP flares.”

“SPEVIGO^® winning the Prix Galien is a great honor! It reinforces our values and mission to bring innovative treatments better and faster to the people that need it most, especially with rare diseases like GPP. GPP flares may appear suddenly, intensify quickly and can be life-threatening if left untreated, leaving those affected and their loved ones feeling anxious and uncertain about their future. We are humbled by the positive impact SPEVIGO^® has had on GPP patients across the world, and take this recognition as a driver to continue our pursuit for their continued benefit,” said Carinne Brouillon, Member of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim.

"We are delighted to extend the Prix Galien legacy to another distinguished cohort of winners who have demonstrated the unparalleled skill, innovation, and dedication required across the life sciences industry,” said Bruno Cohen, Chairman of The Galien Foundation.

Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com

What is SPEVIGO?

SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) flares in adults. It is not known if SPEVIGO is safe and effective in children.

Important Safety Information

Do not receive SPEVIGO if you have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO.

What is the most important information I should know about SPEVIGO?

SPEVIGO may cause serious side effects, including:

• Infections. SPEVIGO may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB after treatment with SPEVIGO. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
  • fevers, chills, or sweats
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm (mucus)
  • burning when you urinate
  • urinating more often than normal
• Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your infusion of SPEVIGO. If you have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you have an infusion-related reaction, your healthcare provider will stop your SPEVIGO infusion and treat your symptoms and may restart SPEVIGO at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms during or after your infusion of SPEVIGO:
  • feeling faint, dizzy, or lightheaded
  • swelling of your face, eyelids, lips, mouth, tongue, or throat
  • trouble breathing or throat tightness
  • fever
  • mouth sores
  • chest tightness
  • hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)
  • itching
  • swollen lymph nodes

Before you receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should not receive live vaccines after treatment with SPEVIGO.
• are pregnant or plan to become pregnant. It is not known if SPEVIGO can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SPEVIGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with SPEVIGO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of SPEVIGO:

• feeling tired or weak
• nausea and vomiting
• headache
• itching or itchy bumps
• a collection of blood under the skin at the infusion site or bruising
• urinary tract infection

These are not all of the possible side effects of SPEVIGO. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

For more information, please see Prescribing Information and Medication Guide.

Boehringer Ingelheim’s Intended Audiences Notice
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

1.Morita et al. Lancet. 2023 Sep 19:S0140-6736(23)01378-8.