Case T-483/22: Judgment of the General Court of 24 September 2025 – Sanofi v Commission (Public health – Medicinal products for human use – Marketing authorisation for the medicinal product Nexviadyme (avalglucosidase alfa) – Non-recognition of avalglucosidase alfa as a new active substance – Directive 2001/83/EC – Regulation (EC) No 726/2004 – Commission document Notice to Applicants, Volume 2A, Procedures for marketing authorisation, Chapter 1, Marketing Authorisation – Standard of proof – Obligation to state reasons – Principle of good administration – Right to be heard – Decision to remove the medicinal product from the European Union Register of Orphan Medicinal Products – Regulation (EC) No 141/2000 – Regulation (EC) No 847/2000 – Significant benefit – Standard of proof – Obligation to state reasons)
Date: 2025-09-24
Institutions: General Court
Subjects: drug surveillance, drugs classification, maladministration, market approval, orphan drug, rights of the defence








C_202505817EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/5817


10.11.2025






Judgment of the General Court of 24 September 2025 – Sanofi v Commission


(Case T-483/22)
                (1)

(Public health - Medicinal products for human use - Marketing authorisation for the medicinal product Nexviadyme (avalglucosidase alfa) - Non-recognition of avalglucosidase alfa as a new active substance - Directive 2001/83/EC - Regulation (EC) No 726/2004 - Commission document ‘Notice to Applicants, Volume 2A, Procedures for marketing authorisation, Chapter 1, Marketing Authorisation’ - Standard of proof - Obligation to state reasons - Principle of good administration - Right to be heard - Decision to remove the medicinal product from the European Union Register of Orphan Medicinal Products - Regulation (EC) No 141/2000 - Regulation (EC) No 847/2000 - Significant benefit - Standard of proof - Obligation to state reasons)
(C/2025/5817)
Language of the case: English

Parties


Applicant: Sanofi BV, formerly Genzyme Europe BV (Amsterdam, Netherlands) (represented by: P. Bogaert, B. Van Vooren and V. Sturla, lawyers)

Defendant: European Commission (represented by: E. Mathieu, M. Owsiany-Hornung and A. Spina, acting as Agents)

Intervener in support of the applicant: European Confederation of Pharmaceutical Entrepreneurs (Eucope) (Brussels, Belgium) (represented by: C. Schoonderbeek, lawyer)

Intervener in support of the defendant: European Medicines Agency (represented by: S. Drosos, H. Kerr, S-M. Kamo and G. Gavriilidou, acting as Agents)

Re:

By its action under Article 263 TFEU, the applicant seeks the partial annulment of Commission Implementing Decision C(2022) 4531 final of 24 June 2022 granting marketing authorisation for Nexviadyme – avalglucosidase alfa, a biological medicinal product for human use, first, in so far as that decision implicitly finds that avalglucosidase alfa is not a new active substance and, second, in so far as Article 5 of that decision states that the medicinal product in question is not to be classified as an orphan medicinal product.

Operative part of the judgment

The Court:






1.


Dismisses the action;










2.


Orders Sanofi BV to bear its own costs and to pay those incurred by the European Commission;










3.


Orders the European Medicines Agency (EMA) and the European Confederation of Pharmaceutical Entrepreneurs (Eucope) to bear their own costs.






(1)  
            OJ C 408, 24.10.2022.


ELI: http://data.europa.eu/eli/C/2025/5817/oj
ISSN 1977-091X (electronic edition)