26 April 2017 EMA/668824/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 18-21 April 2017

During its April 2017 meeting, the CHMP reviewed 5 recommendations for eligibility to PRIME: 1 was granted and 4 were denied. The individual outcomes adopted this month are listed below.

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Eligibility granted Name*

Adeno-associated

Substance type

Advanced therapy

viral vector

Therapeutic area

Haematology -

Therapeutic indication

Treatment of severe haemophilia B

Hemostaseology

Type of data

Type of

supporting request

applicant

Nonclinical

SME

+ Clinical exploratory

serotype 5 containing human factor IX gene (AMT-060) * 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/668824/2016

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Eligibility denied Substance type

Therapeutic area

Therapeutic indication

Type of data supporting

Type of

request

applicant

Other

Chemical

Oncology

Treatment of patients with advanced or metastatic ALKpositive non-small cell lung cancer

Nonclinical

Advanced therapy

Oncology

Treatment of metastatic melanoma

Nonclinical

+ Clinical exploratory SME

+ Clinical exploratory Advanced therapy

Cardiovascular Diseases

Treatment of chronic cardiac ischemia

Nonclinical

Academic

+ Clinical exploratory Chemical

Neurology

Treatment of Rett syndrome

Nonclinical

SME

+ Tolerability first in man 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/668824/2016

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 23 March 2017 By therapeutic area

By type of applicant

* One eligible product has subsequently been withdrawn from the scheme at the applicant’s request

Out of scope 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/668824/2016

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