1 February 2017 EMA/668882/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 23-26 January 2017

During its January 2017 meeting, the CHMP reviewed 10 recommendations for eligibility to PRIME: 2 were granted and 8 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*

Adeno-associated

Substance type

Advanced therapy

Therapeutic area

Neurology

viral vector

Type of data

Type of

supporting request

applicant

Treatment of paediatric patients diagnosed with spinal muscular atrophy Type 1

Nonclinical + Clinical

SME

Treatment of haemophilia A

Nonclinical + Clinical

Therapeutic indication

exploratory

serotype 9 containing the human SMN gene (AVXS-101) Adeno-associated

Advanced therapy

viral vector

Haematology Hemostaseology

Other

exploratory

serotype 5 containing a Bdomain deleted variant of human coagulation factor VIII gene (BMN 270) * 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/668882/2016

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Eligibility denied Substance type

Therapeutic area

Therapeutic indication

Chemical

Oncology

Treatment of hepatocellular carcinoma

Chemical

Endocrinology-GynaecologyFertility-Metabolism

Treatment of Alström Syndrome

Biological

Dermatology

Treatment of moderate to severe atopic dermatitis

Type of data

Type of

supporting request

applicant

Nonclinical + Clinical

SME

exploratory Nonclinical + Clinical

Other

exploratory Nonclinical + Clinical

Other

exploratory Advanced Therapy

Cardiovascular Diseases

Treatment of ischaemic stroke

Chemical

Oncology

Treatment of oral mucositis in head and neck cancer patients receiving chemoradiation therapy

Nonclinical + Clinical

Advanced Therapy

Haematologyhaemostaseology

Treatment of cytomegalovirus-associated viremia or disease after transplant

Nonclinical + Clinical

Biological

Cardiovascular Diseases

Prevention of arteriovenous access dysfunction in haemodialysis patients

Nonclinical + Clinical

Chemical

Infectious diseases

Treatment of cystic fibrosis exacerbations

Nonclinical + Clinical

Nonclinical + Clinical

SME

exploratory SME

exploratory SME

exploratory SME

exploratory SME

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/668882/2016

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 26 January 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/668882/2016

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Recommendations on eligibility to PRIME scheme - European ...

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