FDA Places Clinical Hold on Ionis Drug

The FDA has placed a clinical hold on Ionis Pharmaceuticals’ Phase 3 study to assess IONIS-TTR in patients with transthyretin amyloid cardiomyopathy.

The hold was put in place to allow GlaxoSmithKline to answer questions about the protocol stemming from a separate study evaluating IONIS-TTR in patients with transthyretin familial amyloid polyneuropathy. That study remains on track, with an anticipated completion in the first half of 2017, according to Ionis.

In 2010, the two companies struck a deal through which GSK gained the option to develop and commercialize IONIS-TTR. If GSK exercises its option, it will assume all global development, regulatory and commercial responsibilities, and Ionis will be entitled to upfront and milestone payments.