1 March 2017 EMA/668803/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 20-23 February 2017

During its February 2017 meeting, the CHMP reviewed 5 recommendations for eligibility to PRIME: 2 were granted and 3 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

Therapeutic indication

Haematology Hemostaseology

Treatment of haemophilia B

EndocrinologyGynaecologyFertility-Metabolism

Prevention of acute attacks of hepatic porphyria

Type of data

Type of

supporting request

applicant

Nonclinical

Other

+ Clinical exploratory

containing factor IX gene variant (PF06838435/SPK9001) Givosiran

Chemical

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/668803/2016

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Eligibility denied Substance type

Therapeutic area

Therapeutic indication

Type of data

Type of

supporting request

applicant

SME

Radiopharmaceutical

Oncology

Conditioning treatment for haematopoietic stem cell transplantationin patients with Acute myeloid leukaemia

Nonclinical

Immunological

Infectious Diseases

Prevention of postoperative invasive disease caused by Staphylococcus aureus

Nonclinical

Treatment of antiphospholipid syndrome

Nonclinical

Chemical

ImmunologyRheumatologyTransplantation

+ Clinical exploratory Other

+ Clinical exploratory Academic

+ 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/668803/2016

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Cumulative overview of recommendations on PRIME eligibility requests adopted by 23 February 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/668803/2016

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Mar 1, 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom ... active substance, INN, common name, chemical name or company code. ... of the scheme or with a format and content inadequate to support their.

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