24 May 2017 EMA/668833/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 15-18 May 2017

During its May 2017 meeting, the CHMP reviewed 12 recommendations for eligibility to PRIME: 5 were granted and 7 were denied. The individual outcomes adopted this month are listed below.

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An agency of the European Union

Eligibility granted Name*

Substance type

Therapeutic area

Therapeutic indication

Type of data

Type of

supporting request

applicant

Nonclinical

Other

Asunercept

Biological

Oncology

Treatment of glioblastoma

Olipudase alfa

Biological

EndocrinologyGynaecology-FertilityMetabolism Psychiatry

Treatment of non-neurological manifestations of acid sphingomyelinase deficiency

Nonclinical

Adjunctive treatment of major depressive disorder

Nonclinical

ImmunologyRheumatologyTransplantation

Prevention of graft rejection following solid organ transplantation

Nonclinical

Infectious Diseases

Treatment of chronic hepatitis D infection

Nonclinical

+ Clinical exploratory

Rapastinel

Chemical

Recombinant IgG degrading enzyme of Streptococcus pyogenes

Biological

Synthetic 47-

Chemical

amino-acid N-

Other

+ Clinical exploratory Other

+ Clinical exploratory SME

+ Clinical exploratory

SME

+ Clinical exploratory

myristoylated lipopeptide, derived from the preS region of hepatitis B virus * 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/668833/2016

Page 2/4

Eligibility denied Substance type

Therapeutic area

Therapeutic indication

Type of data

Type of

supporting request

applicant

Biological

Oncology

Treatment of metastatic uveal melanoma

Clinical exploratory

Other

Chemical

Oncology

Treatment of acute myeloid leukaemia

Nonclinical

Other

+ Clinical exploratory Immunological

Oncology

Treatment of pancreatic cancer

Chemical

Infectious Diseases

Treatment of cystic fibrosis exacerbations

Chemical

Immunology-RheumatologyTransplantation

Treatment of diffuse cutaneous systemic sclerosis

Neonatology-Paediatric Intensive Care

Prevention of necrotising enterocolitis

Uro-nephrology

Treatment of calciphylaxis

Nonclinical

SME

+ Clinical exploratory Nonclinical

SME

+ Clinical exploratory

Biological

Chemical

Nonclinical

Other

+ Clinical exploratory Nonclinical

SME

+ Clinical exploratory 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/668833/2016

Page 3/4

Cumulative overview of recommendations on PRIME eligibility requests adopted by 18 May 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/668833/2016

Page 4/4

Recommendations on eligibility to PRIME scheme - European ...

May 24, 2017 - Send a question via our website www.ema.europa.eu/contact. © European ... Name*. Substance type. Therapeutic area. Therapeutic indication.

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