6 June 2018 EMA/116728/2018 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 28-31 May 2018

During its May 2018 meeting, the CHMP reviewed 8 recommendations for eligibility to PRIME: 4 were granted and 4 were denied. The individual outcomes adopted this month are listed below.

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Eligibility granted Name*

Adeno-associated viral vector serotype 8 containing the human MTM1 gene (AT132) Allogeneic umbilical cord blood CD34+ cells cultured ex vivo with Notch ligand Delta1 (NLA101) Autologous T cells transduced with retroviral vector encoding an antiCD19 CD28/CD3-zeta chimeric antigen receptor (KTE-C19) MV-CHIK vaccine

Substance type

Advanced Therapy

Advanced Therapy

Advanced Therapy

Biological

Type of data

Type of

supporting request

applicant

Treatment of X-linked myotubular myopathy

Nonclinical +

SME

ImmunologyRheumatologyTransplantation

Treatment in Haematopoietic Stem Cell Transplantation (HSCT)

Nonclinical +

Oncology

Treatment of adult patients with relapsed or refractory mantle cell lymphoma

Nonclinical +

Prevention of Chikungunya fever

Nonclinical +

Therapeutic area

Other

Vaccines

Therapeutic indication

Clinical exploratory SME

Clinical exploratory

Other

Clinical exploratory

SME

Clinical exploratory * 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.

Recommendations on eligibility to PRIME scheme EMA/116728/2018

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Eligibility denied Substance type

Advanced Therapy

Chemical

Chemical

Therapeutic area

Oncology

Oncology

Dermatology

Type of data

Type of

supporting request

applicant

Treatment of adult patients with B-cell precursor relapsed or refractory acute lymphoblastic leukemia

Nonclinical +

Other

Treatment of relapsed / refractory Diffuse Large B-Cell Lymphoma

Nonclinical +

Treatment of psoriasis

Nonclinical +

Therapeutic indication

Clinical exploratory Other

Clinical exploratory SME

observational data Biological

Uro-nephrology

Treatment of Immunoglobulin A nephropathy

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/116728/2018

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 31 May 2018

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/116728/2018

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3 days ago - Name*. Substance type. Therapeutic area. Therapeutic indication. Type of data supporting request. Type of applicant. Adeno-associated viral.

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