Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 12-15 September 2016
During its September 2016 meeting, the CHMP reviewed 9 recommendations for eligibility to PRIME: 2 were granted and 7 were denied. In addition, 2 requests were received but not started by EMA as they were deemed outside the scope of the scheme. The individual outcomes adopted this month are listed below.
stem cells transduced with lentiviral vector encoding the human βA-T87Qglobin gene (Lentiglobin) * 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/605563/2016
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Eligibility denied Substance type
Chemical
Therapeutic area
Neurology
Therapeutic indication
Treatment of hereditary TTR-mediated amyloidosis
Type of data
Type of
supporting request
applicant
Nonclinical +
Other
Clinical exploratory Chemical Advanced Therapy
Diagnostic Oncology
Diagnostic magnetic resonance imaging for detection and
Nonclinical +
localisation of focal liver lesion
Clinical exploratory
Treatment of glioblastoma multiforme
Nonclinical +
SME Other
Clinical exploratory Advanced Therapy
Immunology-
Treatment of patients diagnosed with severe combined
Nonclinical +
Rheumatology-
immunodeficiency
Clinical exploratory
Other
Transplantation Immunological
Oncology
Treatment of acute myeloid leukaemia
Clinical exploratory
Other
Advanced Therapy
Ophthalmology
Treatment of Leber's Hereditary Optic Neuropathy
Nonclinical +
SME
Clinical exploratory Advanced Therapy
Ophthalmology
Improvement of visual acuity in patients with vision loss from
Nonclinical +
geographic atrophy secondary to age-related macular
Clinical exploratory
Other
degeneration 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/605563/2016
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Cumulative overview of recommendations on PRIME eligibility requests received as of 29 June 2016
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/605563/2016
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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