RegulatoryOfficial

CHMP backs Evumed's generic fondaparinux sodium, referencing Arixtra

🇪🇺 EMA · Fri 13 Nov 2026

The EMA's human medicines committee has recommended marketing authorisation for Fondaparinux sodium Evumed, a generic of Arixtra, across thromboembolism and acute coronary indications.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 12 November 2026, recommending a marketing authorisation for Fondaparinux sodium Evumed. The applicant is Evumed Limited, and the EMA published the opinion summary on 13 November.

The product is a generic of Arixtra, which has been authorised in the EU since 21 March 2002. It will be supplied as a solution for injection in pre-filled syringes at 2.5 mg, 5 mg, 7.5 mg and 10 mg. The active substance, fondaparinux sodium (ATC code B01AX05), is an antithrombotic that blocks Factor Xa to reduce clot formation.

The 2.5 mg/0.5 ml strength is for preventing venous thromboembolic events in adults having major orthopaedic surgery of the lower limbs or high-risk abdominal surgery, and in high-risk medical patients immobilised by acute illness. It also covers treatment of unstable angina or non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction in defined patients, and acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis.

The 5 mg, 7.5 mg and 10 mg strengths are for treating acute deep vein thrombosis and acute pulmonary embolism. This excludes haemodynamically unstable patients and those needing thrombolysis or pulmonary embolectomy.

The EMA says studies showed satisfactory quality. No bioequivalence study against Arixtra was required, because the product is given parenterally and is 100% bioavailable. The summary of product characteristics will be published in all official EU languages once the European Commission grants the authorisation.

What it means for your team

  • Regulatory teams should note that the opinion is positive but the European Commission decision is still pending; the SmPC will follow only after authorisation.
  • The waiver of a bioequivalence study rests on parenteral administration and full bioavailability, a useful precedent for other injectable generics.
  • Market-access and pricing teams may expect another generic fondaparinux competitor to Arixtra once authorised, with four strengths and a split of indications between the lower and higher doses.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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