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.
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
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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
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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
Mar 29, 2017 - SME. Chemical. Oncology. Treatment of locally advanced or ... the scope of the scheme or with a format and content inadequate to support.
Jul 26, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â United ... Name of the active substance, INN, common name, chemical name or company code. ... of the scheme or with a format and content inadequate to support.
Apr 26, 2017 - supporting request. Type of applicant ... Name of the active substance, INN, common name, chemical name or company code. SME applicants ...
3 days ago - Name*. Substance type. Therapeutic area. Therapeutic indication. Type of data supporting request. Type of applicant. Adeno-associated viral.
Nov 16, 2016 - SME applicants are micro-, small-and medium-sized-enterprises ... of the scheme or with a format and content inadequate to support their.
Nov 15, 2017 - Substance type Therapeutic area. Therapeutic indication. Type of data supporting request. Type of applicant. Autologous T lymphocyte- enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor
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
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 ...
Mar 1, 2017 - 30 Churchill Place â Canary Wharf â London E14 5EU â 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.
Dec 20, 2017 - Press office. Recommendations on eligibility to PRIME scheme. Adopted at the CHMP meeting of 11-14 December 2017. During its December 2017 ... requests received but not started by EMA as they were deemed outside the scope of the scheme
Jun 29, 2016 - Name of the active substance, INN, common name, chemical name or company code. SME applicants are micro-, small-and medium-sized-enterprises ... of the scheme or with a format and content inadequate to support their.
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>PRIME aims to bring promising medicines that meet regulatory requirements to patients earlier by optimising and supporting their development. >The scheme ...
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