Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 28-31 May 2018
During its May 2018 meeting, the CHMP reviewed 8 recommendations for eligibility to PRIME: 4 were granted and 4 were denied. The individual outcomes adopted this month are listed below.
Adeno-associated viral vector serotype 8 containing the human MTM1 gene (AT132) Allogeneic umbilical cord blood CD34+ cells cultured ex vivo with Notch ligand Delta1 (NLA101) Autologous T cells transduced with retroviral vector encoding an antiCD19 CD28/CD3-zeta chimeric antigen receptor (KTE-C19) MV-CHIK vaccine
Substance type
Advanced Therapy
Advanced Therapy
Advanced Therapy
Biological
Type of data
Type of
supporting request
applicant
Treatment of X-linked myotubular myopathy
Nonclinical +
SME
ImmunologyRheumatologyTransplantation
Treatment in Haematopoietic Stem Cell Transplantation (HSCT)
Nonclinical +
Oncology
Treatment of adult patients with relapsed or refractory mantle cell lymphoma
Nonclinical +
Prevention of Chikungunya fever
Nonclinical +
Therapeutic area
Other
Vaccines
Therapeutic indication
Clinical exploratory SME
Clinical exploratory
Other
Clinical exploratory
SME
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/116728/2018
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Eligibility denied Substance type
Advanced Therapy
Chemical
Chemical
Therapeutic area
Oncology
Oncology
Dermatology
Type of data
Type of
supporting request
applicant
Treatment of adult patients with B-cell precursor relapsed or refractory acute lymphoblastic leukemia
Nonclinical +
Other
Treatment of relapsed / refractory Diffuse Large B-Cell Lymphoma
Nonclinical +
Treatment of psoriasis
Nonclinical +
Therapeutic indication
Clinical exploratory Other
Clinical exploratory SME
observational data Biological
Uro-nephrology
Treatment of Immunoglobulin A nephropathy
Nonclinical +
SME
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/116728/2018
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Cumulative overview of recommendations on PRIME eligibility requests adopted by 31 May 2018
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/116728/2018
Recommendations on eligibility to PRIME scheme - European ...
3 days ago - Name*. Substance type. Therapeutic area. Therapeutic indication. Type of data supporting request. Type of applicant. Adeno-associated viral.
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 ...
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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