-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
On December 15th, the CDE official website revealed that PB2452 injection (bentracimab) is intended to be included in the breakthrough treatment product.
The indication is for adult patients with uncontrolled bleeding or life-threatening bleeding after receiving ticagrelor treatment, or in emergency surgery or The antiplatelet effect of ticagrelor needs to be reversed before intervention
.
Ticagrelor is a reversible, direct-acting oral P2Y12 receptor inhibitor developed by AstraZeneca.
It is used to prevent and treat acute coronary syndrome (ACS) patients and cardiovascular and cerebrovascular thrombotic events.
It has antiplatelet effects.
, But it also comes with the risk of bleeding
.
PB2452 is a neutralizing monoclonal antibody fragment developed by PhaseBio, which can bind ticagrelor and its active metabolites with high affinity and reverse the antiplatelet effect of ticagrelor
In April 2019, PB2452 was approved by the FDA as a breakthrough therapy for reversing the antiplatelet effect of ticagrelor
.
This designation is based on a phase I clinical data published in the New England Journal of Medicine
Recently, at the 2021 American Heart Association (AHA) annual scientific meeting, PhaseBio announced the results of the pre-designated interim analysis of PB2452 for Phase III clinical (REVERSE-IT)
.
REVERSE-IT is an international multi-center, open-label, single-group phase III clinical trial, which aims to study the effects of PB2452 on patients who have uncontrolled massive or life-threatening bleeding, or who require urgent or invasive surgery.
The reversal effect of ticagrelor's antiplatelet effect is used to support its application for a biological product license (BLA) for major bleeding and emergency surgery indications
.
The study included 150 patients taking ticagrelor and receiving Bentracimab injections, of which 142 received planned emergency surgery (92% of cardiac surgery), and 8 had uncontrolled or life-threatening bleeding
The results showed that PB2452 can immediately and continuously reverse the antiplatelet effect of ticagrelor in patients who need emergency surgery and heavy bleeding, reaching the primary research endpoint
.
After receiving PB2452 treatment for 5-10 minutes, the platelet inhibition rate decreased by 135% (p<0.
