IONIS-HTT Rx (RG6042) Granted PRIME Designation by the European Medicines Agency for the Treatment of People with Huntington's Disease

IONIS-HTT Rx is the first and only drug to demonstrate reduction of mutant huntingtin protein, the underlying cause of Huntington's disease, in patients Roche plans to initiate a pivotal study of IONIS-HTT Rx (RG6042) CARLSBAD, Calif., Aug. 2, 2018 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in antisense therapeutics, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to IONIS-HTTRx (also known as RG6042) for the treatment of people with Huntington's disease (HD). IONIS-HTTRx is the first drug to demonstrate reduction of mutant huntingtin protein, the underlying cause of HD. EMA PRIME (PRIority MEdicines) status is granted to medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. The purpose of the PRIME initiative is to enhance interaction and early dialogue with EU regulators to optimize clinical development and provide a pathway for accelerated assessment of promising medicines.

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