Wednesday 18 October EMA/668873/2016 Press office

Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 9-12 October 2017

During its October 2017 meeting, the CHMP reviewed 7 recommendations for eligibility to PRIME: 3 were granted and 4 were denied. The individual outcomes adopted this month are listed below. Additionally, the CHMP reviewed data on progress to proof of concept and confirmed eligibility for A4250 in the treatment of progressive familial intrahepatic cholestasis, which was initially granted eligibility to the scheme at early stages of development (proof of principle/proof of mechanism) on 13 October 2016.

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An agency of the European Union

Eligibility granted Name*

Entrectinib

Substance

Therapeutic

type

area

Chemical

Oncology

Type of data

Type of

supporting request

applicant

Treatment of NTRK fusion-positive, locally

Nonclinical

SME

advanced or metastatic solid tumours in

+ Clinical exploratory

Therapeutic indication

adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy Humanized antibody targeting B cell

Treatment of relapsed and refractory

Nonclinical

maturation antigen conjugated with

Biological

Oncology

multiple myeloma patients whose prior

+ Clinical exploratory

maleimidocaproyl monomethyl

therapy included a proteasome inhibitor,

auristatin F

an immunomodulatory agent and an anti-

Other

CD38 antibody Human immunoglobulin G1 constant

Biological

region - human ectodysplasin-A1

Dermatology

Treatment of X-linked hypohidrotic

Nonclinical

ectodermal dysplasia

+ Clinical exploratory

Other

receptor-binding domain fusion protein * 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/668873/2016

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Eligibility denied Substance type

Chemical

Therapeutic area

Pneumology-Allergology

Therapeutic indication

Treatment of Idiopathic Pulmonary Fibrosis

Type of data

Type of

supporting request

applicant

Nonclinical

Other

+ Clinical exploratory Advanced Therapy Biological

Cardiovascular Diseases Neurology

Treatment of patients with acute myocardial

Nonclinical

infarction

+ Clinical exploratory

Treatment of metachromatic leukodystrophy

Nonclinical

SME Other

+ Clinical exploratory Chemical

Haematology - Hemostaseology

Treatment of Sickle Cell Disease

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/668873/2016

Page 3/4

Cumulative overview of recommendations on PRIME eligibility requests adopted by 12 October 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/668873/2016

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Recommendations on eligibility to PRIME scheme - European ...

Oct 18, 2017 - Additionally, the CHMP reviewed data on progress to proof of concept and confirmed eligibility for A4250 in the treatment of progressive familial intrahepatic cholestasis, which was initially granted eligibility to the scheme at early stages of development (proof of principle/proof of mechanism) on 13 October ...

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