Emicizumab is under clinical development by Chugai Pharmaceutical and currently in Phase II for Acquired Hemophilia A. According to GlobalData, Phase II drugs for Acquired Hemophilia A does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Emicizumab LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Emicizumab overview

Emicizumab (Hemlibra / RG-6013 / ACE-910) is a humanized monoclonal modified immunoglobulin G4 (IgG4) bi-specific antibody acts as an anti-factor IXa- and anti-factor X or anti-haemophilic agent. It is formulated as injectable solution for subcutaneous route of administration. Hemlibra is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors, and also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages, newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors. Hemlibra is indicated for the routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with acquired hemophilia A. 

Emicizumab is under development for the treatment of acquired mild to moderate hemophilia A and Von Willebrand Disease (vWD).

Chugai Pharmaceutical overview

Chugai Pharmaceutical (Chugai), a subsidiary of Hoffmann-La Roche Ltd, is focused on the research, development, commercialization, manufacturing, import and export of biopharmaceuticals and therapeutic antibodies. The company offers products for the treatment of various therapeutic areas including, cancer; bone and joint diseases; renal diseases; immune disorders and infectious diseases and others. It also offers drugs to aid the kidney, liver and other organ transplants. It also has a range of product candidates in its pipeline. Operating through its network of subsidiaries, the company offers its pharmaceutical products in overseas markets including North America, Europe and Asia. Chugai is headquartered in Tokyo, Japan.

For a complete picture of Emicizumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.