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Abatacept

Published
Topics: AbataceptCCG commissioned new medicinesMusculo-skeletal disorders · New MedicinesNHS England commissioned new medicinesPatent expiriesSafety in BreastfeedingStability outside the fridge ·
Contents
  1. dm+d
  2. Refrigerated Storage
    1. Orencia · Bristol-Myers Squibb
    2. Orencia · Bristol-Myers Squibb
  3. Lactation Safety Information
  4. New Medicines
    1. Orencia · Idiopathic inflammatory myopathies (IIM) in adults
    2. abatacept biosimilar (M834) · Rheumatoid arthritis (RA)

dm+d

421412005

Refrigerated Storage

OrenciaBristol-Myers Squibb

Bristol-Myers Squibb
Orencia
Pre-filled syringe and pre-filled pen

Contact Bristol-Myers Squibb in all cases where deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

21 May 2019
London MI Service

OrenciaBristol-Myers Squibb

Bristol-Myers Squibb
Orencia
250mg powder for concentrate for solution for infusion

Contact Bristol-Myers Squibb in all cases where deviation from the recommended storage conditions has occurred.Refer to the current BNF for company contact details.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

21 May 2019
London MI Service

Lactation Safety Information

Caution
See summary
Long half-life increases risk of accumulation in breastfed infants
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
Avoid in preterm infants and neonates as large protein molecules may appear in colostrum
16 September 2020
LactMed

New Medicines

OrenciaIdiopathic inflammatory myopathies (IIM) in adults

Information

Orencia
Licence extension / variation
Bristol-Myers Squibb
Bristol-Myers Squibb

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

T cell co-stimulation blocker
IIM are a heterogeneous group of diseases that are characterised by inflammation of muscle tissue (myositis) which can lead to profound weakness, fatigue and disability. A base case study in Sweden indicated that the estimated incidence of IIM between 2007 and 2011 was 11 (13 for women and 9.7 for men) per 1,000,000 person years [1].
Idiopathic inflammatory myopathies (IIM) in adults
Subcutaneous injection

abatacept biosimilar (M834)Rheumatoid arthritis (RA)

Information

abatacept biosimilar (M834)
Biosimilar
Momenta
Momenta

Development and Regulatory status

Phase I Clinical Trials
Phase I Clinical Trials
Phase I Clinical Trials
Feb 21No mention of development of M834 in Johnson & Johnson latest annual report or pipeline - assume no further development [10,11].
Oct 20Johnson & Johnson acquires Momenta [8].

Category

Biosimilar of abatacept, a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1).
NICE suggest the benchmark rate for the number of people with RA eligible for and receiving biologic drugs is 86 per 100,000 adults per year
Rheumatoid arthritis (RA)
Parenteral