Roche gets some reg­u­la­to­ry love for its break­through quest on a PhI­II Hunt­ing­ton's drug

Roche got a boost to­day in its quest to steer a po­ten­tial­ly land­mark Hunt­ing­ton’s drug through piv­otal de­vel­op­ment. The EMA hand­ed Roche its PRIME des­ig­na­tion for RG6042 — once called IO­N­IS-HT­TRx when Io­n­is was do­ing the work. 

Sim­i­lar to the FDA’s break­through ther­a­py des­ig­na­tion, Eu­ro­pean reg­u­la­tors will give Roche an open door at the drug agency as the phar­ma gi­ant launch­es a Phase III study of the drug, which has joined the line­up of Roche’s late-stage show­case ef­forts.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER