20 December 2017 EMA/668784/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 11-14 December 2017

During its December 2017 meeting, the CHMP reviewed 7 recommendations for eligibility to PRIME: 7 were denied. The individual outcomes adopted this month are listed below.

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Eligibility denied Substance type

Therapeutic area

Therapeutic indication

Chemical

Oncology

Treatment of familial adenomatous polyposis

Chemical

Oncology

Treatment of acute myeloid leukaemia

Chemical

Oncology

Treatment of acute myeloid leukaemia

Chemical

Oncology

Chemical

Neurology

Treatment of patients with unresectable or metastatic tumours with a specific gene fusion/translocation Treatment of acute sudden sensorineural hearing loss

Chemical

Immunology-RheumatologyTransplantation Endocrinology-GynaecologyFertility-Metabolism

Advanced Therapy

Treatment of Pemphigus Treatment and prevention of progression of Type I Diabetes Mellitus in paediatric patients

Type of data

Type of

supporting request

applicant

Nonclinical + Clinical exploratory Nonclinical + Clinical exploratory Nonclinical + Clinical exploratory Nonclinical + Clinical exploratory Nonclinical + Clinical exploratory Nonclinical + Clinical exploratory Nonclinical + Clinical exploratory

SME SME Other Other SME SME 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 or not fulfilling the definition of academic sponsors.

Recommendations on eligibility to PRIME scheme EMA/668784/2016

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 14 December 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/668784/2016

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Recommendations on eligibility to PRIME scheme - European ...

Dec 20, 2017 - Press office. Recommendations on eligibility to PRIME scheme. Adopted at the CHMP meeting of 11-14 December 2017. During its December 2017 ... 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.

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