Renta 4 | The company has announced FDA approval for the launch in the US of the new fibrinogen concentrate FESILTY for adult and paediatric patients with congenital fibrinogen deficiency. FESILTY is a product developed by Biotest, which will be marketed in the US by Grifols.
The company expects FESILTY to be available to US patients experiencing acute bleeding episodes caused by this protein deficiency from the first half of 2026. The fibrinogen concentrate expands the company’s portfolio in haematological indications.
Assessment: While this is good news, we do not expect it to have a significant impact on short-term results. Although the use of fibrinogen is widespread in Europe, its use in the US will increase over time as products become available and awareness of its therapeutic advantages grows. We do expect it to have a significant impact in Europe from its launch (already marketed in Germany by Biotest, with new launches expected throughout 2026), where approval is also expected to include the indication of ‘acquired fibrinogen deficiency’, an indication for which the company will continue to conduct clinical trials before applying for approval in the US.
