FDA seeks advice on screening patients potentially at higher risk for liver and other injuries, strategies to implement before or after gene therapy administration to head off or mitigate potential adverse events, and whether upper limits should be set for the total vector genome dose and total capsid dose.

Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.

Incyte welcomed FDA approval of its ruxolitinib cream, a selective JAK1/JAK2 inhibitor, as a treatment for atopic dermatitis, but criticized the boxed warnings label assigned to it.