dm+d

421412005

Refrigerated Storage

OrenciaBristol-Myers Squibb Pharmaceuticals Ltd

Bristol-Myers Squibb Pharmaceuticals Ltd
Orencia
Pre-filled syringe and pen

Contact Bristol-Myers Squibb Pharmaceuticals Ltd 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

24 September 2021
London MI Service

OrenciaBristol-Myers Squibb Pharmaceuticals Ltd

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

Contact Bristol-Myers Squibb Pharmaceuticals Ltd 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

24 September 2021
London MI Service

Lactation Safety Information

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

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

OrenciaGraft versus host disease (GvHD)

Information

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

Development and Regulatory status

None
None
Approved (Licensed)
Dec 21Approved for prevention of moderate to severe acute GvHD in pts aged >2 years who have received unrelated donor hematopoietic stem cell transplantation (HSCT). Approval was under Priority Review conducted under Project Orbis.[5]
Dec 21Has orphan drug designation for this indication in US. [5]
Aug 21FDA accept sBLA for Priority Review, with a PDUFA of 23/12/21 [4].
Dec 19Granted breakthrough therapy status in US for prevention of moderate to severe aGVHD [3].

Category

T-cell co-stimulation modulator. 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).
The number of allogeneic bone marrow and stem cell transplants is increasing worldwide. GvHD is a serious complication of this type of transplant. The incidence of acute GvHD varies widely, ranging from 10-80% depending on risk factors. Acute GvHD relates to the degree of HLA mismatch; thus, it is usual to try to match donors and recipients for these proteins, especially HLA-A, -B, -C and DRB1 [1].
Graft versus host disease (GvHD)
Acute - prophylaxis in patients aged 6 years and older in unrelated donor HSCT
Subcutaneous injection

Trial or other data

Dec 21Data from the GVHD-1 study shows that pts with severe disease who received abatacept saw a 97% overall survival rate vs. 84% for placebo. For moderate-severe aGVHD-free survival, this was 50% with abatacept vs. 32% with placebo. [5]
Aug 21Data from the PII ABA2 trial showed that when abatacept was added to a standard GvHD prophylactic regimen administered to pts with hematologic malignancies who received a stem cell transplant from an unrelated, HLA-matched or mismatched donor, there was a significant reduction in severe aGvHD. Associated morbidity was also reduced without an increase in disease relapse. Pts who received abatacept saw a 98% overall survival rate vs. 75% for pts who received standard immunosuppression [5,6]
Jun 18Collection of primary outcome data completes in PII trial (NCT01743131). Follow-up continues until Feb 23 [2].
Feb 13PII trial to assess if abatacept can be used together with a calcineurin inhibitor (cyclosporine or tacrolimus) and methotrexate to provide better protection against aGvHD without causing more infections starts (NCT01743131). 186 patients aged 6 years and older with a willing unrelated adult donor (bone marrow or peripheral blood) who may have a single mismatch (i.e. be a 7/8) and this mismatch may be at the allele or antigen level will be recruited in the US and Canada. Primary outcome is the cumulative incidence of severe aGVHD at day +100 post-transplant; collection of these data is due to complete Jun 18 [2].

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