The European Medicines Agency (EMA) granted PRIME designation for the Huntingtin-lowering (sometimes called gene silencing) antisense drug, known as HTTRx or RG6042, for the treatment of people with Huntington’s disease. This means that the EMA supports the development of the drug to target an unmet need, speeding up evaluation so that patients can benefit as soon as possible.
Read the announcement here http://ir.ionispharma.com/news-releases/news-release-details/ionis-htt-rx-rg6042-granted-prime-designation-european-medicines
Pharmaceutical company Roche plans to carry out a study in which it will evaluate how the drug works in a larger patient population, assessing its safety and seeing if it can slow the progression of the disease in adults. The study will begin towards the end of 2018 or early 2019.
Huntington’s disease research news website HD Buzz said, via Twitter:
“PRIME [stands for] PRIority MEdicines designation – it gives faster handling for the process of getting a drug licensed in Europe, as soon as positive results come out of a suitable clinical trial. This means RG6042 has already been recognised by the European drugs regulator as being of potentially major importance in a disease with no effective treatments. “Accelerated assessment reduces the EMA’s decision-making time by about 60 days in most cases. Roche will also get more dedicated advice and input from the EMA during the testing of the drug.”
John Eden, Chief Executive, said:
“It’s great to see Rcohe are on their toes and doing everything in their power to achieve the goal of bringing a treatment to people with HD as soon as is practicably possible. We know however there are many hurdles yet to clear before hope becomes reality.”
HD Buzz said: “This [priority designation] only helps if the data from the planned efficacy trial and associated programmes are good. We still have to work together to test the drug.”
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