Povofortay

Opinion

EMA has issued an opinion on this medicine

povorcitinib

Overview

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Povofortay, intended for the treatment of hidradenitis suppurativa.

The applicant for this medicinal product is Incyte Biosciences Distribution B.V.

Povofortay will be available as 45 mg and 75 mg film-coated tablets. The active substance of Povofortay is povorcitinib, a Janus-associated kinase 1 (JAK1) inhibitor (ATC code: not yet assigned). By inhibiting JAK1-dependent cytokine signalling (including IL-6, IL-2 and IL-22), povorcitinib prevents immune cell activation and attenuates skin and systemic inflammation associated with hidradenitis suppurativa.

The benefit of Povofortay is its ability to reduce the number of skin lesions and pain caused by hidradenitis suppurativa in patients previously treated with anti-TNF therapy, compared to placebo. The most common side effects with Povofortay are upper respiratory tract infections, folliculitis, urinary tract infection, hyperlipidaemia, headache, acne and blood creatine phosphokinase increased.

The full indication is:

Povofortay is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults who have responded inadequately to, or who are intolerant or contraindicated to an anti-TNF therapy.

Povofortay treatment should be initiated and supervised by physicians experienced in the diagnosis and treatment of hidradenitis suppurativa.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Povofortay

Adopted Reference Number: EMADOC-1829012207-69603

Product details

• Name of medicine:
  Povofortay
• Active substance:
  povorcitinib phosphate
• International non-proprietary name (INN) or common name:
  povorcitinib
• Therapeutic area (MeSH):
  Hidradenitis Suppurativa
• EMA product number:
  EMEA/H/C/006727
• Marketing authorisation applicant:
  Incyte Biosciences Distribution B.V.
• Opinion adopted:
  17/09/2026
• Opinion status:
  Positive