21 September 2016 EMA/605563/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 12-15 September 2016

During its September 2016 meeting, the CHMP reviewed 9 recommendations for eligibility to PRIME: 2 were granted and 7 were denied. In addition, 2 requests were received but not started by EMA as they were deemed outside the scope of the scheme. The individual outcomes adopted this month are listed below.

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Eligibility granted Name*

Autologous CD3+

Substance type

Advanced Therapy

Therapeutic area

Oncology

T Cells Expressing

Type of data

Type of

supporting request

applicant

Treatment of relapsed/refractory adult B-cell

Nonclinical +

Other

Acute Lymphoblastic Leukaemia (ALL)

Clinical exploratory

Treatment of transfusion-dependent beta-

Nonclinical +

thalassaemia (also referred to as beta-

Clinical exploratory

Therapeutic indication

CD19 Chimeric Antigen Receptor (JCAR015) Autologous

Advanced Therapy

CD34+

Haematology Hemostaseology

haematopoietic

SME

thalassaemia major)

stem cells transduced with lentiviral vector encoding the human βA-T87Qglobin gene (Lentiglobin) * 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/605563/2016

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Eligibility denied Substance type

Chemical

Therapeutic area

Neurology

Therapeutic indication

Treatment of hereditary TTR-mediated amyloidosis

Type of data

Type of

supporting request

applicant

Nonclinical +

Other

Clinical exploratory Chemical Advanced Therapy

Diagnostic Oncology

Diagnostic magnetic resonance imaging for detection and

Nonclinical +

localisation of focal liver lesion

Clinical exploratory

Treatment of glioblastoma multiforme

Nonclinical +

SME Other

Clinical exploratory Advanced Therapy

Immunology-

Treatment of patients diagnosed with severe combined

Nonclinical +

Rheumatology-

immunodeficiency

Clinical exploratory

Other

Transplantation Immunological

Oncology

Treatment of acute myeloid leukaemia

Clinical exploratory

Other

Advanced Therapy

Ophthalmology

Treatment of Leber's Hereditary Optic Neuropathy

Nonclinical +

SME

Clinical exploratory Advanced Therapy

Ophthalmology

Improvement of visual acuity in patients with vision loss from

Nonclinical +

geographic atrophy secondary to age-related macular

Clinical exploratory

Other

degeneration 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/605563/2016

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Cumulative overview of recommendations on PRIME eligibility requests received as of 29 June 2016

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/605563/2016

Page 4/4

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