South Korea’s GC Biopharma (KRX: 006280) has presented evidence suggesting that Roche’s (SWX: ROG) hemophilia therapy, Hemlibra (emicizumab), may display a higher proportion of thrombotic adverse events (AEs) compared to coagulation factor VIII replacements. This finding is based on an analysis of US data reported to the FDA Adverse Event Reporting System (FAERS) between 2018 and 2022.
Analysis of Thrombotic Adverse Events
GC Biopharma’s analysis revealed that thrombotic AEs accounted for 4.07% of AEs associated with Hemlibra, while only 1.44% were linked to factor VIII replacements. This represents a 2.8-fold difference in frequency, which is consistent with data reported earlier this year from Europe. The company emphasized the need for further research to understand the potential greater risk of thrombotic AEs associated with Hemlibra.
Implications for Roche and Hemlibra
While GC Biopharma has underscored the importance of additional research into these findings, it remains unclear whether this report will have any impact on the performance of Hemlibra. The product continues to be a key growth driver for Roche, and any safety concerns could potentially influence its market position and patient treatment choices.-Fineline Info & Tech
