26 July 2017 EMA/668852/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 17-20 July 2017

During its July 2017 meeting, the CHMP reviewed 8 recommendations for eligibility to PRIME: 1 was granted and 7 were denied. The individual outcomes adopted this month are listed below.

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Eligibility granted Name*

Vocimagene

Substance type

Advanced Therapy

Therapeutic area

Oncology

Therapeutic indication

Treatment of high grade glioma

amiretrorepvec

Type of data

Type of

supporting request

applicant

Nonclinical

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/668852/2016

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Eligibility denied Substance type

Biological

Therapeutic area

Oncology

Therapeutic indication

Treatment of metastatic melanoma C

Type of data

Type of

supporting request

applicant

Nonclinical

Other

+ Clinical exploratory Chemical

Oncology

Treatment of cholangiocarcinoma

Nonclinical

SME

+ Clinical exploratory Advanced Therapy

Neurology

Treatment of ischaemic stroke

Nonclinical

SME

+ Clinical exploratory Chemical

Ophthalmology

Treatment of neurotrophic keratitis

Nonclinical

SME

+ Clinical exploratory Chemical

Dermatology

Treatment of chronic hand eczema

Advanced Therapy

Oto-rhino-laryngology

Treatment of genetic muscular disorder

Nonclinical

Other

+ Clinical exploratory Nonclinical

Academic

+ Clinical exploratory Biological

Other

Treatment of light chain amyloidosis

Nonclinical

Other

+ 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/668852/2016

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 20 July 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* One eligible product has subsequently been withdrawn from the scheme at the applicant’s request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/668852/2016

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Recommendations on eligibility to PRIME scheme - European ...

Jul 26, 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United ... Name of the active substance, INN, common name, chemical name or company code. ... of the scheme or with a format and content inadequate to support.

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