The National Authority for Medicines and Health Products (Infarmed) announced on Thursday that the drug Spevigo (spesolimab) has been authorized for hospital use, specifically for monotherapy treatment of generalized pustular psoriasis (GPP) exacerbations in adult patients.
The public assessment report is available on Infarmed’s website or through this link.
According to the document, the “green light” was given on the 6th of the month, with the evaluated medication corresponding to a “single dose of 900 mg (2 vials of 450 mg for injection) administered as an intravenous infusion.”
“If GPP exacerbation symptoms persist, an additional 900 mg dose can be administered one week after the initial dose,” Infarmed details.
The same document provides insights into the disease in question, beginning with psoriasis, described as a “common dermatological disease characterized by the appearance of scaly and erythematous plaques, encompassing a wide spectrum of presentations.”
Regarding GPP, it is defined as “a less frequent subtype characterized by intense granulocytic infiltration in the epidermis leading to the appearance of sterile pustules.”
Infarmed explains that this subtype can present either “acutely or subacutely on areas of erythematous skin” and primarily affects adults, although it can occur in children as well.
“It may occur independently but can be associated with other pre-existing forms of psoriasis,” they explain.
The document details the study methodology and results, which can be reviewed on the final pages. For example, on page 32, it is noted that in terms of ‘nearly clear skin by validated scale,’ observations showed “statistical significance.”
“Based on the results of the pharmacotherapeutic assessment and economic evaluation, and following negotiations for better conditions for the National Health Service, the use of the drug in hospital settings is admitted, considering the specific characteristics of both the medication and the disease, as well as its budgetary impact,” the specialists conclude.
