STAT+: Following dispute with FDA, UniQure is cleared to submit Huntington’s treatment for approval

The Food and Drug Administration has reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for its maker, the biotech company Uni Qure, to file for U.S. approval, the company said Wednesday.&#x A0; Uni Qure will submit a marketing application in the third quarter seeking accelerated approval for the treatment, called AMT-130. The decision comes after a recent meeting with FDA officials during which the agency agreed that a three-year analysis of an early-stage study that showed a benefit for patients with Huntington’s was “acceptable” to support a marketing application, the company said.  These are the same AMT-130 data that former FDA officials, most notably Commissioner Marty Makary and Vinay Prasad, the agency’s top regulator of cell and gene therapies, previously concluded were insufficient to support a marketing application. Continue to STAT+ to read the full story…