Recommendations on eligibility to PRIME scheme Adopted at the CHMP meeting of 23-26 January 2017
During its January 2017 meeting, the CHMP reviewed 10 recommendations for eligibility to PRIME: 2 were granted and 8 were denied. In addition, 1 request was received but not started by EMA as it was deemed outside the scope of the scheme. The individual outcomes adopted this month are listed below.
Treatment of paediatric patients diagnosed with spinal muscular atrophy Type 1
Nonclinical + Clinical
SME
Treatment of haemophilia A
Nonclinical + Clinical
Therapeutic indication
exploratory
serotype 9 containing the human SMN gene (AVXS-101) Adeno-associated
Advanced therapy
viral vector
Haematology Hemostaseology
Other
exploratory
serotype 5 containing a Bdomain deleted variant of human coagulation factor VIII gene (BMN 270) * 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/668882/2016
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Eligibility denied Substance type
Therapeutic area
Therapeutic indication
Chemical
Oncology
Treatment of hepatocellular carcinoma
Chemical
Endocrinology-GynaecologyFertility-Metabolism
Treatment of Alström Syndrome
Biological
Dermatology
Treatment of moderate to severe atopic dermatitis
Type of data
Type of
supporting request
applicant
Nonclinical + Clinical
SME
exploratory Nonclinical + Clinical
Other
exploratory Nonclinical + Clinical
Other
exploratory Advanced Therapy
Cardiovascular Diseases
Treatment of ischaemic stroke
Chemical
Oncology
Treatment of oral mucositis in head and neck cancer patients receiving chemoradiation therapy
Nonclinical + Clinical
Advanced Therapy
Haematologyhaemostaseology
Treatment of cytomegalovirus-associated viremia or disease after transplant
Nonclinical + Clinical
Biological
Cardiovascular Diseases
Prevention of arteriovenous access dysfunction in haemodialysis patients
Nonclinical + Clinical
Chemical
Infectious diseases
Treatment of cystic fibrosis exacerbations
Nonclinical + Clinical
Nonclinical + Clinical
SME
exploratory SME
exploratory SME
exploratory SME
exploratory SME
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/668882/2016
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Cumulative overview of recommendations on PRIME eligibility requests adopted by 26 January 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/668882/2016
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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