FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA Accepts Five Drugs for Priority Medicine Program

June 5, 2017

The European Medicines Agency named five treatments as eligible for its priority medicines program, bringing the total to 25.

The five new products granted PRIME eligibility cover various diseases and conditions, including hepatitis D, acid sphingomyelinase deficiency and major depressive disorder. Two of the candidates, Sanofi’s olipudase alfa and Allergan’s rapastinel, previously received FDA breakthrough designations.

The EMA denied seven candidates, including three oncology treatments, a cystic fibrosis drug and a biological treatment for prevention of necrotizing enterocolitis.

The majority of the 20 products the agency previously accepted were for oncology or hematology. In a recently-released report on the PRIME program’s first year, the agency noted that of the 71 rejections it issued, 70 percent were for insufficient data, 40 percent were for inadequate justification of therapeutic advantage, and 20 percent were because the candidate was too far along in the development process.

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