[Alpha Biz=(Chicago) Reporter Kim Jisun] Two of Korea's leading pharmaceutical companies are engaged in a war of nerves over the results of studies on side effects related to treatments.

According to the industry, GC Biopharma reported to the media on the 21st that the rate of 〈Emiciumab' blood clot abnormality was 2.8 times higher than that of 'Factor VIII concentrate’' I distributed a press release titled 〉. The 8th factor drug is a hemophilia treatment of GC Biopharma, and hemlibra is a hemophilia treatment of JW Pharmaceutical.

The data is an analysis of "Thrombotic side effects of patients injected with factor VIII concentrate and emicizumab (name of Hemlibra)" jointly by GC Biopharma, Sungkyunkwan University's College of Pharmacy and the Korea Hyeolwoo Foundation at the Society for Bleeding Disorder (BDC) held in the U.S. from the 17th to the 19th.

According to GC Biopharma, the study is a comparative analysis of blood clot side effects of emicizumab and Factor 8 agent based on data reported to the US FDA Abnormal Case Reporting System (FAERS). As a result, a total of 233 abnormal cases occurred after emicizumab administration, of which 97 were found to be blood clot abnormalities. It was analyzed that blood clot abnormalities in emicizumab accounted for 4.07% of all abnormalities.

The GC Biopharma stressed that emicizumab's blood clot abnormality rate was 2.83 times higher than that of the 8-factor drug injection group (1.44%).

The next day, JW Pharmaceutical issued a rebuttal. "The FDA drug abnormal case reporting system announced by GC Biopharma is a voluntary abnormal case reporting system, and not all abnormal cases have been collected," JW said. "In order to compare the incidence of abnormal reactions between products, we need the number of abnormal cases compared to the total number of administered patients in each product, but there are only abnormal cases reported to the FDA." Therefore, the conclusion that the emicizumab has about three times the report rate of blood clot abnormalities compared to factor VIII concentrate is a rapid interpretation.

Rather, in terms of market share in the U.S., the total number of abnormal cases of factor VIII concentrate was 9,324, higher than 2,383 cases of emicizumab. He then stressed, "I am very sorry for the act of officially disparaging each product by directly referring to competitors' drugs without considering that the release date and reporting standards of each product are different."

"The study was conducted on the premise that both emicizumab and factor VIII concentrate are the same," GC Biopharma said in an explanation. "The study was not intended to raise or disparage the safety of a particular company's products."

 

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