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Efmoroctocog alfa

Alternative Names: efmoroctocog alfa, biib-031, biib 031, biib031, elocta, Eloctate
Latest Update: 2024-12-01
Latest Update Note: PubMed Publication

Product Description

Mechanisms of Action: FVIII Analogue

Novel Mechanism: Yes

Modality: Coagulation Factor

Route of Administration: Intravenous

FDA Designation: None *

Approval Status: Not Approved

Approved Countries: Australia | Austria | Belgium | Brazil | Chile | Colombia | Croatia | Cyprus | Denmark | Estonia | France | Germany | Hong Kong | Hungary | Iceland | Italy | Japan | Luxembourg | Netherlands | New Zealand | Norway | Portugal | Russia | Saudi Arabia | Spain | Taiwan | Tunisia | Turkey | United Arab Emirates | United Kingdom | United States

Approved Indications: None

Known Adverse Events: None

Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Efmoroctocog alfa

Countries in Clinic:

Active Clinical Trial Count:

Highest Development Phases

Phase 4: Hemophilia A

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
INHIBIT

P3

Withdrawn

Hemophilia A

2027-07-01

A-MORE

N/A

Active, not recruiting

Hemophilia A

2026-04-01

CHALE

N/A

Recruiting

Hemophilia B|Hemophilia A

2024-06-01

Sobi.HAEM89-007

P4

Unknown Status

Hemophilia A

2023-12-01

Recent News Events

Date

Type

Title

12/01/2024

PubMed

 An observational study of haemophilia A patients without inhibitors using the French national claims (SNDS) database.

06/19/2024

News Article

 European Commission grants Sobi® Marketing Authorisation for ALTUVOCT™ for treatment of haemophilia A

04/26/2024

News Article

 Sobi® receives positive CHMP opinion recommending approval of efanesoctocog alfa for once-weekly treatment of haemophilia A

04/09/2024

PubMed

 Factor VIII moiety of recombinant Factor VIII Fc fusion protein impacts Fc effector function and CD16(+) NK cell activation.

03/01/2024

PubMed

 Variability in combinations of APTT reagent and substrate plasma for a one-stage clotting assay to measure factor VIII products.

11/20/2023

News Article

 Sobi to present new data at ASH 2023 Annual Meeting

09/26/2023

News Article

 [2023-2031] Japonica Rice Market Size, Research Report

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