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Boehringer Ingelheim secures HSA approval for stroke treatment

Newsflash Asia

- November 14, 2025

Boehringer Ingelheim has announced that its thrombolytic medication, MetalyseR (tenecteplase), has received approval from Singapore’s Health Sciences Authority (HSA) for the treatment of acute ischaemic stroke (AIS) in adults. This approval allows the drug to be administered within 4.5 hours from the last known well time, a critical window for effective stroke intervention.

Acute ischaemic stroke is a leading cause of death and long-term disability worldwide, and in Singapore, it accounts for 5.8% of deaths. The approval of MetalyseR is based on evidence from the AcT trial, which demonstrated that tenecteplase, at a dosage of 0.25 mg/kg, improves the likelihood of patients living independently post-stroke.

The European Stroke Organisation has recommended tenecteplase as an alternative to the current standard treatment, alteplase, due to its ease of administration. Unlike alteplase, which requires a one-hour infusion, tenecteplase is delivered as a single injection over 5 to 10 seconds. This efficiency could enhance hospital operations and conserve healthcare resources.

Tenecteplase is anticipated to become a new standard of care for AIS, supported by its inclusion in global stroke care guidelines. The approval marks a significant advancement in stroke treatment options available in Singapore, potentially improving outcomes for patients and reducing the burden on healthcare systems.

This story was selected and published by a human editor, with content adapted from original press material using AI tools. Spot an error? Report it here.

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