EMA Adds Four New Drugs to PRIME Scheme

Regulatory NewsRegulatory News | 27 July 2016 |  By 

The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight.

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 product assessment.

Thus far, the program appears to be holding true to its mandate to advance cutting-edge products. Of the four new drugs accepted, three are considered advanced therapies, with the other product being Merck's investigational Ebola vaccine.

The scheme has also managed to draw strong interest from small- and medium-sized enterprises (SMEs), with nine of the 17 newly reviewed applications coming from such organizations.

New PRIME Medicines

The four drugs were accepted to the PRIME scheme during two recent Committee for Medicinal Products for Human Use (CHMP) meetings in June and July, joining the four previous drugs accepted into the program at the committee's May meeting.

During the meetings, CHMP also denied PRIME eligibility to 13 other drugs, bringing the total number of drugs denied from the program to 27. Additionally, EMA says it has received two applications to the program that were deemed "out of scope" and were not reviewed.

So far, there is a great deal of overlap between drugs accepted to PRIME and those granted breakthrough therapy designation, with five of the eight PRIME drugs already being designated as breakthrough therapies.

Additionally, oncology remains the largest area of focus for companies applying to the program, accounting for more than one third (12/35) of the total submissions and half of (4/8) the accepted products.

Products Granted PRIME Eligibility
CompanyName/Active SubstanceTypeIndicationSupporting DataFDA Breakthrough Designation
NovartisCTL019Advanced TherapyRelapsed or refractory B cell acute lymphoblastic leukemia in pediatric patientsNonclinical + Clinical exploratoryYes
MerckEbola Zaire vaccineBiological (Vaccine)Ebola (Zaire Strain)Nonclinical + Clinical exploratoryYes
AdaptimmuneNY-ESO-1c259TAdvanced TherapyInoperable or metastatic synovial sarcoma in patients who have received prior chemotherapy and whose tumor expresses the NY-ESO-1 tumor antigenNonclinical + Clinical exploratoryYes
DNATrixDNX-2401Advanced TherapyRecurrent glioblastoma in patients where gross total resection is not possible or advisable.Nonclinical + Clinical exploratoryNo (Fast Track)

As with the first batch of drugs reviewed for PRIME eligibility, nearly all of the new applicants relied on a combination of nonclinical and clinical exploratory data to support their submissions. Of the 17 new applications, only three relied on different types of data, none of which were accepted. Of those, two relied solely on clinical exploratory data, and one relied on nonclinical evidence and first-in-human tolerability data.

June, July Recommendations on Eligibility to PRIME Scheme


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