PureTech Gets FDA Orphan Designation for LYT-200 in Acute Myeloid Leukemia

By Colin Kellaher

PureTech Health has won U.S. Food and Drug Administration orphan-drug designation for its LYT-200 drug candidate for the treatment of acute myeloid leukemia.

The Boston clinical-stage biotherapeutics company, which is conducting a Phase 1b study of LYT-200 in relapsed/refractory acute myeloid leukemia, on Wednesday said long-term survival rates in the targeted patient population are very poor.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

03-13-24 0742ET