Two-year follow-up data for double-antibody treatment of hemophilia A: safe and effective medical Mai Meng broke the news

Recent popular reports from Yimaike ★Dry productsCDE acceptance numbers of new domestic biologic drugs maintain the same upward trend compared with the previous month, and the development of ADC, double antibodies, CAR-T is in full swing.
★Dry productsDouble anti-tide, magnificent click on the picture, sign up now July 21, 2021 /MedClub News/--Genentech recently announced that long-term follow-up data of Hemlibra® (emicizumab-kxwh) in the treatment of advanced hemophilia A shows that there are no new problems in its safety and the ability to control bleeding has remained consistent.
Sex
.

Hemlibra is a bispecific monoclonal antibody targeting coagulation factor IXa and coagulation factor X.
It is designed to replace the function of activated factor VIII.
It has been approved in more than 100 countries for the treatment of factor VIII inhibitors in the body.
Hemophilia
.

Factor VIII is an essential protein in the coagulation process.
Therefore, compared with hemophilia patients without factor VIII inhibitors, hemophilia A patients with factor VIII inhibitors have a higher bleeding frequency and daily life.
The challenge is also greater
.

The drug has also been approved in more than 80 countries for the treatment of hemophilia A without factor VIII inhibitors
.

In this phase 3b STASEY study, the tested patients were 193 hemophilia A patients with factor VIII inhibitors and received prophylactic Hemlibra once a week for two years
.

The median duration of treatment was 103.
1 weeks
.

The results showed that there were no new cases of thrombotic microangiopathy or serious thrombotic events related to the study drug
.

The most common adverse events (AE) included arthralgia (17.
1%), common cold symptoms (15.
5%), headache (15.
0%), injection site reactions (11.
4%) and fever (10.
9%)
.

Approximately 35% of patients experienced drug-related AEs, the most common being injection site reactions (9.
8%)
.

Only 5.
2% (n=10) of the participants were positive for anti-drug antibodies (ADAs), indicating that Hemlibra is associated with a low incidence of ADA
.

A total of 5 ADAs-positive patients can be detected in vitro with neutralizing ADAs
.

The development of ADA in these 10 tested patients showed no impact on the efficacy or safety of the study drug
.

Over time, the ADA disappeared, and all participants tested negative at the last study visit
.

Approximately 82.
6% of patients had no bleeding events during the managed treatment period, which proved that the use of Hemlibra treatment in the long-term follow-up can effectively control the bleeding
.

Genentech said in a statement that the annual bleeding rate in this analysis is consistent with data from its key trial HAVEN study
.

Dr.
Levi Garraway, chief medical officer and head of global product development of Genentech, said: “With the development of the treatment prospects, the first task is still to determine the long-term benefits or risk status of the drug for patients with hemophilia A, because the body contains factor VIII inhibitors.
The population of hemophilia A patients has historically faced major treatment challenges
.

These results can further prove Hemlibra’s favorable safety profile
.

"About Hemlibra and Hemophilia A treatment Hemlibra has been popular since its launch in 2017 market
.

In 2018, Hemlibra's sales in the United States reached 154 million U.
S.
dollars and global sales reached 224 million Swiss francs.
In 2019, global sales increased by 516% to 1.
38 billion Swiss francs
.

In 2018, Hemlibra was accelerated by China's National Medical Products Administration (NMPA) and became the first bispecific antibody drug approved in China
.

Its phase 3 clinical study HAVEN 5 is a confirmatory trial approved after the agreement with the Chinese health department, which aims to provide supporting data for patients with hemophilia A in China
.

Recommended reading: Hemophilia treatment: Roche's bispecific antibodies continue to escort, and gene therapy is the next frontier | Yimai Meng broke the news.
Looking around, the current global market for gene therapy for hemophilia A is fiercely competitive
.

For example, in addition to Roche/Genentech’s Hemlibra, there are: SPK-8011 developed by Roche/Spark; giroctocogene fitelparvovec (SB-525) jointly developed by Pfizer and Sangamo; etranacogene dezaparvovec developed by uniQure; and valocococogene roxaparvec developed by BioMarin.
BAY2599023 (DTX201, AAVhu37 FVIII) jointly developed by Bayer and Ultragenyx Pharmaceuticals; ASC618 developed by ASC Therapeutics; FLT210 developed by Freeline; SHP654 jointly developed by Shire/Baxalta; etc.
, have all entered the clinical stage
.

Recommended reading: BioMarin's application for the AAV gene therapy for hemophilia has been accepted by the EMA.
Yimai Meng broke the news.
Roche/Spark announced the latest clinical data on hemophilia A gene therapy.
Yimai Meng broke the news about lower doses! The U.
S.
FDA approved the "high secretory" protein optimization strategy AAV gene therapy to enter the clinic for the treatment of hemophilia A.
Yimai Meng broke the news! Hemophilia gene therapy company Freeline has landed on Nasdaq with an initial IPO of up to 125 million U.
S.
dollars Yimai Meng broke the news! The hemophilia gene therapy market is expanding rapidly and will exceed US$780 million in 2026 | Yimai Meng broke the news reference materials: 1.
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