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- Analyzed the FDA FAERS data…to compare the thrombotic AEs of Hemlibra vs. FVIII replacements.
YONGIN, South Korea, Aug. 18, 2023 /PRNewswire/ — GC Biopharma (006280.KS), a South Korean biopharmaceutical company, announced on August 17, 2023 that it has presented the results of analyzing and comparing thrombotic adverse events(AEs) of Hemlibra (emicizumab) and Factor FVIII replacements reported in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) at the Bleeding Disorder Conference (BDC) currently being held in Maryland, U.S. from August 17 to August 19, 2023.
BDC, organized by National Hemophilia Foundation (NHF), is an international conference and is routinely attended by nearly 2,700 people, including researchers, physicians and other healthcare professionals, industry representatives, NHF chapters, patients, and families. This year’s conference marks the 75th anniversary.
The results of the study shared by GC Biopharma holds significance in that it is an outcome of research collaboration between industry, university, and hemophilia treatment center, represented respectively by BongKyoo Choi, ScD MPH RPh, Vice President of Department of Research and Development in GC Biopharma, Professor Ju-Young Shin from Sungkyunkwan University, and Ki Young Yoo M.D., Ph.D. of Korea Hemophilia Foundation.
According to the study, which analyzed the FAERS data of the past 5 years (from 2018 to 2022), out of total 2,383 AEs associated with Hemlibra, 97 AEs (4.07%) were thrombotic AEs. By contrast, the proportion of thrombotic AEs for FVIII replacements was 1.44% (134 thrombotic AEs out of total 9,324 AEs associated with FVIII replacements) during the same period. That is, when compared, thrombotic AEs of Hemlibra were 2.83 times more frequent than those of FVIII replacements. In the early of this year, similar findings were reported in in a European pharmacovigilance study using the Eudravigilance database[i]. The study showed that thrombotic AEs were about 2.77 times more frequently reported for Hemlibra than for EHL FVIII replacements.
It is also notable in the study shared by GC Biopharma that the thrombotic AEs of Hemlibra were still 1.84 times more frequently reported than those of FVIII replacements even after excluding the AEs of Hemlibra with bypassing agents (BPAs).
In fact, it has been known in initial clinical trials that when used together with BPAs such as activated prothrombin complex concentrate (aPCC), Hemlibra increases the risk for thrombotic microangiopathy in some Hemophila A patients. Yet, in the study shared by GC Biopharma, out of total 97 thrombotic AEs of Hemlibra, 62 AEs were reported without BPAs which is higher than 35 AEs with BPAs as co-reported drugs .
“This is the first study of analyzing and comparing thrombotic AEs of Hemlibra and FVIII replacements using the real-world data reported in FAERS” said Ki Young Yoo, M.D., Ph.D., Korea Hemophilia Foundation, “More future research and efforts are warranted for monitoring, elucidating, and preventing the potential greater risk of thrombotic AEs of Hemlibra.”
Details of the presentation are as follows:
Title: Comparison of thrombotic adverse events in patients treated with factor VIII replacements and emicizumab using the 2018-2022 FAERS data.
Poster Number: QOL4
Session Day and Time: Thursday, August 17, 2023 from 11:00 AM to 4:00 PM.
Presenter: BongKyoo Choi, ScD MPH RPh, Vice President of Department of Research and Development in GC Biopharma
The poster can be viewed here.
About GC Biopharma
GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century.
This press release may contain biopharmaceuticals in forward-looking statements, which express the current beliefs and expectations of GC Biopharma’s management. Such statements do not represent any guarantee by GC Biopharma or its management of future performance and involve known and unknown risks, uncertainties and other factors. GC Biopharma undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule.
GC Biopharma Contacts (Media)
Seunghyun Baek
seunghyun.baek@gccorp.com
Sohee Kim
shkim20@gccorp.com
Yelin Jun
yelin@gccorp.com
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[i] Maria A et al. J Thromb Haemost. 2023;21(3):546-552 |