15 November 2017 EMA/668793/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 6-9 November 2017

During its November 2017 meeting, the CHMP reviewed 9 recommendations for eligibility to PRIME: 3 were granted and 6 were denied. In addition, 1 request was received but not started by EMA as it was deemed outside the scope of the scheme. The individual outcomes adopted this month are listed below.

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Eligibility granted Name*

Substance type

Autologous T lymphocyte-

Advanced

enriched population of

therapy

Therapeutic area

Oncology

Type of data

Type of

supporting request

applicant

Treatment of relapsed and refractory

Nonclinical +

Other

multiple myeloma patients whose prior

Clinical exploratory

Therapeutic indication

cells transduced with a

therapy included a proteasome inhibitor, an

lentiviral vector encoding

immunomodulatory agent and an anti-CD38

a chimeric antigen

antibody

receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (bb2121) LR12

Chemical

Infectious Diseases

Treatment of Septic Shock

Nonclinical +

SME

Tolerability first in man Recombinant humanised

Biological

Other

monoclonal IgG2 lambda

Treatment of osteogenesis imperfecta types

Nonclinical +

I, III and IV

Clinical exploratory

SME

antibody against human sclerostin (BPS804) * Name of the active substance, INN, common name, chemical name or company code. SME applicants are micro-, small-and medium-sized-enterprises registered with the Agency’s SME office. Other types of applicants are those not qualifying or not registered as SME or not fulfilling the definition of academic sponsors. Product(s) in italic have been granted eligibility to the scheme at early stages of development (proof of principle/proof of mechanism).

Recommendations on eligibility to PRIME scheme EMA/668793/2016

Page 2/4

Eligibility denied Substance type

Biological

Therapeutic area

Oncology

Therapeutic indication

Treatment of non-muscle invasive bladder cancer

Type of data

Type of

supporting request

applicant

Nonclinical +

Other

Clinical exploratory Chemical

Oncology

Treatment of breast cancer in men

Nonclinical +

SME

Clinical exploratory Biological

Haematology -

Prevention of bleeding in patients with haemophilia B

Hemostaseology Chemical

Neurology

Nonclinical +

SME

Clinical exploratory Treatment of Huntington's disease

Nonclinical +

Other

Clinical exploratory Chemical

Neurology

Treatment of X-linked Adrenoleukodystrophy

Nonclinical +

SME

Tolerability first in man Biological

Immunology-RheumatologyTransplantation

Treatment of steroid resistant acute Graft-Versus-Host Disease

Nonclinical +

SME

Clinical exploratory

SME applicants are micro-, small-and medium-sized-enterprises registered with the Agency’s SME office. Other type of applicants are those not qualifying or not registered as SME or not fulfilling the definition of academic sponsors.

Recommendations on eligibility to PRIME scheme EMA/668793/2016

Page 3/4

Cumulative overview of recommendations on PRIME eligibility requests adopted by 9 November 2017

By therapeutic area

By type of applicant

* This indicates eligibility requests received but not started by EMA as they were deemed outside the scope of the scheme or with a format and content inadequate to support their

review. These are not included in the breakdown by type of applicant or by therapeutic area. Recommendations on eligibility to PRIME scheme EMA/668793/2016

Page 4/4

Recommendations on eligibility to PRIME scheme - European ...

Nov 15, 2017 - Substance type Therapeutic area. Therapeutic indication. Type of data supporting request. Type of applicant. Autologous T lymphocyte- enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human. B cell maturation antigen with 4-1BB and CD3-zeta.

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