FDA adds ‘break­through’ sta­tus for Al­ny­lam as patisir­an starts its vic­to­ry lap at the agency

With Al­ny­lam’s rolling ap­pli­ca­tion for its land­mark RNA ther­a­py patisir­an just weeks from com­ple­tion, the FDA has come through with a break­through drug des­ig­na­tion that may well trim its time to mar­ket.

The Cam­bridge/Boston biotech re­port­ed this morn­ing that the agency had is­sued its BTD — pro­vid­ing VIP sta­tus at the agency — based on some stel­lar Phase III da­ta in hered­i­tary transthyretin-me­di­at­ed AT­TR amy­loi­do­sis — or hAT­TR amy­loi­do­sis.

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