EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25

Regulatory NewsRegulatory News | 26 May 2017 |  By 

The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25.

The agency also said it denied seven requests for eligibility, which seeks to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors.

While this latest batch of recommendations saw a higher proportion of treatments accepted to the program, the overall acceptance rate remains at 23%.

Last week, EMA reported on the program's first year (April 2016-April 2017), noting that of the 71 requests it denied during that time, 70% of applications did not contain sufficiently robust data, 40% provided insufficient justification of therapeutic advantage and 20% were too far along in development to be candidates.

However, the agency also touted the promising nature of the products it chose to accept for the program, almost half of which are advanced therapies (12/25). One-third of the therapies accepted are for diseases with no existing treatments.

The five newly accepted products cover a range of disease areas, including hepatitis D, glioblastoma, major depressive disorder and the ultra-rare genetic disorder acid sphingomyelinase deficiency. Previously, oncology and hematology products have dominated, representing 12 of the 20 products accepted in the program's first year.

Products Granted PRIME Eligibility in May 2017
CompanyName/Active SubstanceTypeIndicationSupporting DataFDA Breakthrough Designation
ApogenixAsunercept (APG101)BiologicalGlioblastomaNonclinical + Clinical ExploratoryNo
Sanofi GenzymeOlipudase alfaBiologicalAcid sphingomyelinase deficiencyNonclinical + Clinical ExploratoryYes
AllerganRapastinelChemicalAdjunctive treatment of major depressive disorderNonclinical + Clinical ExploratoryYes
Hansa MedicalRecombinant IgG degrading enzyme of Streptococcus pyogenesBiologicalPrevention of graft rejection following solid organ transplantationNonclinical + Clinical ExploratoryNo
MYR GmbHMyrcludex BChemicalTreatment of chronic hepatitis D infectionNonclinical + Clinical ExploratoryNo



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