4 July 2018 EMA/284962/2018 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 25-28 June 2018

During its June 2018 meeting, the CHMP reviewed 4 recommendations for eligibility to PRIME: 3 were granted and 1 was denied. The individual outcomes adopted this month are listed below.

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Eligibility granted Name*

Deoxycytidine /

Substance type

Chemical

deoxythymidine Mycobacterium

Immunological

Therapeutic area

Therapeutic indication

Type of data

Type of

supporting request

applicant

Nonclinical +

SME

EndocrinologyGynaecology-FertilityMetabolism

Treatment of Thymidine Kinase 2 Deficiency

Vaccines

Active immunization against tuberculosis disease

Nonclinical +

in newborns, adolescents and adults

Tolerability first in man

Treatment of obesity and the control of hunger

Nonclinical +

associated with deficiency disorders of the MC4R

Clinical exploratory

tuberculosis

Clinical exploratory SME

(MTBVAC) Setmelanotide

Chemical

EndocrinologyGynaecology-FertilityMetabolism

SME

receptor pathway

* 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. Product(s) in italic have been granted eligibility to the scheme at early stages of development (proof of principle/proof of mechanism).

Recommendations on eligibility to PRIME scheme EMA/284962/2018

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Eligibility denied Substance type

Biological

Therapeutic area

Oncology

Therapeutic indication

Treatment of adult patients with HER2-positive breast cancer

Type of data

Type of

supporting request

applicant

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/284962/2018

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 28 June 2018 Corr*

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. *Figures corrected on page 4. Recommendations on eligibility to PRIME scheme EMA/284962/2018

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Recommendations on eligibility to PRIME scheme - European ...

Jul 4, 2018 - *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 ...

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