EMA Accepts Four Products to Priority Medicines Scheme

Regulatory NewsRegulatory News | 01 June 2016 |  By 

The European Medicines Agency (EMA) on Wednesday released its first statistics for its PRIority MEdicines (PRIME) scheme, naming the first four products to become eligible for the program, which seeks to speed the development of promising new drugs and biologics.

This is the first time EMA has released data signaling industry interest in PRIME since its launch in March. In total, EMA says it received 18 applications, mostly from small- and medium-sized companies, representing a range of therapeutic areas, including infectious disease, oncology, immunology and neurology.

Figure 1. Applications to PRIME by Therapeutic Area

Therapeutic Area

Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated assessment of the product.

At its launch, EMA Executive Director Guido Rasi said the program was needed because, too often, drugmakers' development plans are inadequate or fail to generate the data EMA is looking for. Rasi added, "This is especially true for those developers that have less regulatory experience."

PRIME Statistics

The newly released statistics detail EMA's decisions on applications to the PRIME program during its first month in operation.

In total, EMA says it received 11 of the 18 applications from small- and medium-sized companies. However, EMA says it only granted PRIME eligibility to four of the 18 applications:

Figure 2. Products Granted PRIME Eligibility
CompanyName/Active SubstanceTypeIndicationSupporting DataFDA Breakthrough Therapy Designation
BiogenAducanumabBiologicalAlzheimer's DiseaseNonclinical + Clinical ExploratoryNo
ChemoCentryxCCX168ChemicalANCA Associated VasculitisNonclinical + Clinical ExploratoryNo
Kite PharmaKTE-C19Advanced TherapyDiffuse Large B-Cell LymphomaNonclinical + Clinical ExploratoryYes
NovimmuneNI-0501BiologicalPrimary Hemophagocytic LymphohistiocytosisNonclinical + Clinical ExploratoryYes

The vast majority of applications to PRIME relied on both nonclinical and clinical exploratory data to demonstrate eligibility and their promise to meet an unmet medical need.

Only three applications relied on other combinations of evidence, none of which were granted PRIME eligibility. Of those products, one included clinical confirmatory data alongside nonclinical and clinical exploratory data; one relied on nonclinical data and a first-in-human tolerability study; and one relied only on nonclinical and "other" evidence.

EMA Press Release, Eligibility Decisions


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