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30 Churchill Place Canary Wharf London E14 5EU United Kingdom

An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5550

Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

1 June 2016 EMA/345382/2016 Press office

Recommendations on eligibility to PRIME scheme

Adopted at the CHMP meeting of 23-26 May 2016

During its May 2016 meeting, the CHMP reviewed 18 recommendations for eligibility to PRIME: 4 were granted and 14 were denied.

The individual outcomes adopted this month are listed below.

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Recommendations on eligibility to PRIME scheme

EMA/345382/2016 Page 2/5

Eligibility granted

Name* Substance type Therapeutic area Therapeutic indication Type of data supporting request

Type of applicant

Aducanumab Biological Neurology Treatment of Alzheimer’s disease Nonclinical +

Clinical exploratory

Other

CCX168 Chemical Immunology-

Rheumatology- Transplantation

Treatment of patients with active ANCA- associated vasculitis (including granulomatosis with polyangiitis and microscopic polyangiitis)

Nonclinical + Clinical exploratory

SME

KTE-C19 Advanced Therapy Oncology Treatment of adult patients with diffuse large B- cell lymphoma (DLBCL) who have not responded to their prior therapy, or have had disease progression after autologous stem cell transplant (ASCT)

Nonclinical + Clinical exploratory

SME

NI-0501 Biological Haematology-

Hemostaseology

Treatment of primary haemophagocytic lymphohistiocytosis (HLH)

Nonclinical + Clinical exploratory

SME

* 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.

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Recommendations on eligibility to PRIME scheme

EMA/345382/2016 Page 3/5

Eligibility denied

Substance type Therapeutic area Therapeutic indication Type of data

supporting request

Type of applicant

Advanced Therapy Oncology Treatment of adult patients with primary mediastinal B-cell lymphoma (PMBCL)

Non clinical + Clinical exploratory

SME

Advanced Therapy Oncology Treatment of adult patients with transformed follicular lymphoma (TFL)

Non clinical +

tolerability first in man

SME

Chemical Infectious Diseases Treatment of serious bacterial infections Nonclinical +

Clinical exploratory + Clinical confirmatory

Other

Chemical Infectious Diseases Prevention of poliomyelitis Nonclinical +

Clinical exploratory

SME

Biological Infectious Diseases Treatment of adult patients with active recurrent Clostridium difficile infection

Nonclinical + Clinical exploratory

SME

Biological Vaccines Prevention of respiratory syncytial virus (RSV) disease in adults 60 years of age and older

Nonclinical + Clinical exploratory

Other

Biological Vaccines Prevention of lower respiratory tract infection due to RSV in infants ≤6 months of age

Nonclinical + Clinical exploratory

Other

Biological Pneumology-Allergology Treatment of peanut allergy Nonclinical +

Clinical exploratory

SME

Herbal Pneumology-Allergology Treatment of peanut allergy Clinical exploratory Other

Biological Pneumology-Allergology Prevention of acute attacks of hereditary angioedema Nonclinical + Clinical exploratory

Other

Biological Immunology-Rheumatology- Transplantation

Treatment of steroid-resistant acute graft-versus-host disease Nonclinical + Clinical exploratory

SME

Chemical Neurology Adjunctive treatment of super-refractory status epilepticus Nonclinical + Clinical exploratory

Other

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Recommendations on eligibility to PRIME scheme

EMA/345382/2016 Page 4/5

Substance type Therapeutic area Therapeutic indication Type of data

supporting request

Type of applicant

Advanced Therapy Cardiovascular Diseases Adjunct therapy for adult heart failure patients undergoing coronary arterial bypass graft (CABG)

Nonclinical + Clinical exploratory

SME

Chemical Ophthalmology Treatment of neurotrophic keratitis Nonclinical + other SME

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.

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Recommendations on eligibility to PRIME scheme

EMA/345382/2016 Page 5/5

Cumulative overview of recommendations on PRIME eligibility requests received as of 6 April 2016 By therapeutic area

By type of applicant

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