FDA Approves Fesilty for Acute Bleeding in Congenital Fibrinogen Deficiency
Here’s a breakdown of the key information from the provided text, focusing on the new fibrinogen concentrate (FESILTY™/BT524):
Key Findings & Information about FESILTY™ (fibrinogen, human-chmt):
* Approval: The US FDA has approved a new fibrinogen concentrate, FESILTY™ (fibrinogen, human-chmt).
* Patient Population: Studied in both adults and pediatric patients.
* Efficacy:
* IVR (Incremental In Vivo Recovery): 1.88 mg/dL per mg/kg. This indicates how much fibrinogen activity is restored in the body after infusion.
* MCF (Maximum Clot Firmness): Significantly increased after infusion.
* adults: Mean increase of 11.1 mm (95% CI, 9.33-14.47; *P* < .0001).
* Pediatric Patients: Increase ranged from 9.3 to 16.5 mm.
* Duration of Effect: The increase in MCF was maintained for up to 8 hours.
* safety:
* Adverse Events: 31 treatment-emergent AEs were reported in 55.6% of patients.
* Treatment-Related AEs: Incidence was very low.
* Contraindications: Severe hypersensitivity reactions (including anaphylaxis) to the drug or its components.
References:
- Grifols press release announcing FDA approval: https://www.grifols.com/en/view-news/-/news/grifols-receives-us-fda-approval-for-new-fibrinogen-concentrate-fesiltytm-fibrinogen-human-chmt
- MedlinePlus information on congenital fibrinogen deficiency (incomplete citation).
In essence, the text presents FESILTY™ as a promising new fibrinogen concentrate with demonstrated efficacy in increasing clot firmness and a generally favorable safety profile, though hypersensitivity remains a contraindication.