Attrogy

Opinion

EMA has issued an opinion on this medicine

diflunisal

Overview

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Attrogy , intended for the treatment of hereditary transthyretin-mediated amyloidosis (ATTRv) in adult patients with stage 1 or stage 2 polyneuropathy.

The applicant for this medicinal product is Purpose Pharma International AB.

Attrogy will be available as 250 mg film-coated tablets. The active substance of Attrogy is diflunisal (ATC code: Salicylic acid and derivatives. ATC code: NO2BA11). Diflunisal stabilises the transthyretin (TTR) tetramer, preventing its dissociation into TTR monomers which are responsible for TTR amyloidosis pathology.

The benefits of Attrogy are its ability to delay disease progression, measured by the Neuropathy Impairment Score plus 7 nerve tests (NIS+7), at 2 years of treatment versus placebo, as shown in a randomised, double-blind, placebo-controlled clinical trial. The most common side effects are gastro-intestinal.

The full indication is:

Attrogy is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Attrogy

AdoptedReference Number: EMA/CHMP/134824/2025

Product details

• Name of medicine:
  Attrogy
• Active substance:
  diflunisal
• International non-proprietary name (INN) or common name:
  diflunisal
• Therapeutic area (MeSH):
  Amyloid Neuropathies, Familial
• Anatomical therapeutic chemical (ATC) code:
  N02BA11
• EMA product number:
  EMEA/H/C/006248
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  Purpose Pharma International AB
• Opinion adopted:
  25/04/2025
• Opinion status:
  Positive