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30 Jul 2025
Admin
News Article

FDA Grants Orphan Drug Designation to COAGADEX for Rare Bleeding Disorder

Kedrion Biopharma has received Orphan Drug Designation (ODD) from the U.S. FDA for Coagulation Factor X (human)—marketed as COAGADEX—for the treatment of acquired Factor X Deficiency (aFXD), a rare bleeding disorder affecting fewer than 1 in 1,000,000 people globally.

Additionally, the FDA has issued a “Study May Proceed” letter to begin a clinical trial assessing COAGADEX in active bleeding episodes and perioperative bleeding management in patients with aFXD associated with AL amyloidosis.

About COAGADEX

A plasma-derived coagulation factor concentrate
Approved in 38 countries for:
- Routine prophylaxis to reduce bleeding frequency
- On-demand treatment and control of bleeding episodes
- Perioperative bleeding management
Indicated for hereditary Factor X deficiency in adults and children

Details of the New FDA-Approved Trial

Target: Patients with aFXD caused by AL amyloidosis
Mechanism: Amyloid fibrils bind Factor X, shortening its half-life and increasing bleeding risk
Objective: To evaluate whether COAGADEX can restore hemostasis in this patient group

Trial features:

First site activation underway
Includes patients with moderate to severe aFXD (FX:C levels <50%)

Leadership Commentary

“Receiving orphan drug designation for COAGADEX in aFXD is a significant milestone. It underscores the unmet need in this space and Kedrion’s commitment to rare disease care.”

Bob Rossilli, Chief Commercial Officer at Kedrion Biopharma.

“This trial is pivotal for expanding COAGADEX’s reach beyond hereditary FXD. We're pushing forward precision treatment in rare bleeding disorders.”

Nisha Jain, VP, Global Clinical Development and Strategy.

About Kedrion Biopharma

A global biopharmaceutical company producing plasma-derived therapies
Focus areas: Coagulation and neurological disorders, primary immunodeficiencies, Rh sensitization and hemolytic disease of the newborn
5,200+ employees worldwide

Important Safety Information for COAGADEX

Hypersensitivity risks (including anaphylaxis)
- Discontinue immediately and seek medical attention if symptoms occur
Risk of neutralizing antibodies (inhibitors)
- Regular clinical and lab monitoring recommended
Potential presence of infectious agents (e.g., viruses, vCJD, CJD)
- No documented cases of transmission to date
Common adverse reactions (≥5% of subjects in clinical trials):
- Infusion site erythema and pain
- Fatigue
- Back pain

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