Recommendations on eligibility to PRIME scheme
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1 1 June 2016 EMA/345382/2016 Press office Adopted at the CHMP meeting of May 2016 During its May 2016 meeting, the CHMP reviewed 18 recommendations for eligibility to PRIME: 4 were granted and 14 were denied. The individual outcomes adopted this month are listed below. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.
2 Eligibility granted Name* Substance type Therapeutic area Therapeutic indication data Aducanumab Biological Neurology Treatment of Alzheimer s disease Nonclinical + CCX168 Chemical Immunology- Treatment of patients with active ANCAassociated Nonclinical + Rheumatology- Transplantation vasculitis (including granulomatosis with polyangiitis and microscopic polyangiitis) KTE-C19 Advanced Therapy Oncology Treatment of adult patients with diffuse large B- Nonclinical + cell lymphoma (DLBCL) who have not responded to their prior therapy, or have had disease progression after autologous stem cell transplant (ASCT) NI-0501 Biological Haematology- Hemostaseology Treatment of primary haemophagocytic lymphohistiocytosis (HLH) Nonclinical + * Name of the active substance, INN, common name, chemical name or company code. s are micro-, small-and medium-sized-enterprises registered with the Agency s office. types of s are those not qualifying or not registered as. EMA/345382/2016 Page 2/5
3 Eligibility denied Substance type Therapeutic area Therapeutic indication data Advanced Therapy Oncology Treatment of adult patients with primary mediastinal B-cell Non clinical + lymphoma (PMBCL) Advanced Therapy Oncology Treatment of adult patients with transformed follicular Non clinical + lymphoma (TFL) tolerability first in man Chemical Infectious Diseases Treatment of serious bacterial infections Nonclinical + + Clinical confirmatory Chemical Infectious Diseases Prevention of poliomyelitis Nonclinical + Biological Infectious Diseases Treatment of adult patients with active recurrent Clostridium Nonclinical + difficile infection Biological Vaccines Prevention of respiratory syncytial virus (RSV) disease in Nonclinical + adults 60 years of age and older Biological Vaccines Prevention of lower respiratory tract infection due to RSV in Nonclinical + infants 6 months of age Biological Pneumology-Allergology Treatment of peanut allergy Nonclinical + Herbal Pneumology-Allergology Treatment of peanut allergy Biological Pneumology-Allergology Prevention of acute attacks of hereditary angioedema Nonclinical + Biological Immunology-Rheumatology- Treatment of steroid-resistant acute graft-versus-host disease Nonclinical + Transplantation Chemical Neurology Adjunctive treatment of super-refractory status epilepticus Nonclinical + EMA/345382/2016 Page 3/5
4 Substance type Therapeutic area Therapeutic indication data Advanced Therapy Cardiovascular Diseases Adjunct therapy for adult heart failure patients undergoing Nonclinical + coronary arterial bypass graft (CABG) Chemical Ophthalmology Treatment of neurotrophic keratitis Nonclinical + other s are micro-, small-and medium-sized-enterprises registered with the Agency s office. type of s are those not qualifying or not registered as. EMA/345382/2016 Page 4/5
5 Cumulative overview of recommendations on PRIME eligibility requests received as of 6 April 2016 By therapeutic area By type of EMA/345382/2016 Page 5/5
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