Boehringer Ingelheim received approval from the U.S. Food and Drug Administration (FDA) on Sept. 1, 2022, for Spevigo® (spesolimab-sbzo) injection. The interleukin-36 receptor (IL-36R) inhibitor treats adults who are experiencing potentially life-threatening flare-ups of generalized pustular psoriasis (GPP). A rare form of psoriasis, GPP causes itchy, painful blisters that spread and form scabs over large parts of the skin surface. Spevigo is the first drug FDA approved to treat GPP. It is administered in a 90-minute intravenous (IV) infusion as a one-time dose of 900mg (two vials). If the flare has not resolved after one week, the dose may be repeated, once. Distribution will be exclusively through Accredo within one week. Cost information is not yet available. Prescribing information can be found here.
At a Glance
- Brand (Generic) Name: Spevigo (spesolimab-sbzo)
- Manufacturer: Boehringer Ingelheim
- Date Approved: Sept. 1, 2022
- Indication: for the treatment of generalized pustular psoriasis flares in adults
- Dosage Forms Available: single-dose vials containing 450mg of Spevigo in 7.5mL of solution for reconstitution and IV infusion
- Launch Date: Within one week
- Estimated Annual Cost: Not yet available
- The least common form of psoriasis, GPP is believed to affect less than 0.05% of the general population. Although the two conditions are different, about three-quarters of patients who have GPP also have plaque psoriasis.
- GPP generally is diagnosed for patients between the ages of 40 years old and 60 years old. Slightly more women are affected than men, some ethnic groups have higher incidences, and some patients have greater genetic risk due to mutations in specific genes.
- The major symptom of GPP is recurring episodes of widespread skin inflammation that causes pustules — small blisters that fill with pus. The pustules spread, forming larger lesions that split open and then form scabs. Other symptoms may include fatigue, fever, and elevated white blood cell counts.
- Flares can be spontaneous or associated with factors such as infectious diseases, some medications, pregnancy, or stress. Severe flares can result in heart or kidney failure or sepsis.
- Spevigo blocks the receptors for IL-36, a protein that promotes inflammation in GPP.
- A clinical study enrolled 53 patients who mostly had extensive skin coverage by pustules. After one week, pustules cleared for 54% of participants who were treated with Spevigo. In comparison, only 6% of patients given a placebo infusion had cleared skin.
- Treatment with Spevigo may increase the risk of infections. Seventeen percent of patients receiving treatment reported an infection within the first week following therapy, compared to about 6% of those receiving placebo.
- No other drugs are FDA approved to treat GPP, but the immunosuppressant, cyclosporine, and tumor-necrosis factor (TNF) blockers, such as infliximab, are used off-label to manage flares.
- Designated as both a Breakthrough Therapy and an Orphan Drug, Spevigo was approved under the FDA’s Priority Review process.