16 November 2016 EMA/615021/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 7-10 November 2016

During its November 2016 meeting, the CHMP reviewed 7 recommendations for eligibility to PRIME: 1 was granted and 6 were denied. The individual outcomes adopted this month are listed below.

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Eligibility granted Name*

Allopregnanolone

Substance type

Chemical

Therapeutic area

Psychiatry

Therapeutic indication

Treatment of Postpartum depression

(SAGE-547)

Type of data

Type of

supporting request

applicant

Nonclinical +

Other

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/615021/2016

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Eligibility denied Substance type

Therapeutic area

Therapeutic indication

Advanced therapy

Oncology

Treatment of mesothelioma

Chemical

GastroenterologyHepatology

Treatment of patients with non-alcoholic steatohepatitis

Neurology

Treatment of tics associated with Tourette syndrome

Type of data

Type of

supporting request

applicant

Nonclinical +

SME

Clinical exploratory

Chemical

Nonclinical +

SME

Clinical exploratory Nonclinical +

Other

Clinical exploratory Chemical

Dermatology

Treatment of systemic sclerosis

Nonclinical

SME

+ Tolerability first in man Advanced therapy Advanced therapy

Cardiovascular Diseases Cardiovascular Diseases

Treatment of Critical Limb Ischemia in subjects with Diabetes Mellitus

Nonclinical +

Adjunct therapy for adult heart failure patients undergoing coronary arterial bypass graft (CABG)

Nonclinical +

SME

Clinical exploratory SME

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/615021/2016

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Cumulative overview of recommendations on PRIME eligibility requests received until 21 September 2016

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/615021/2016

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