Alnylam must wait a few months longer for a verdict on its potential blockbuster-in-waiting vutrisiran.
The U.S. FDA has slapped a three-month delay on its review of the RNA interference (RNAi) hopeful after Alnylam tapped a new production facility to support the drug’s launch. The regulator needs the extra time to inspect and sign off on a contractor's packaging and labeling plant, Alnylam said in a release Monday.
Alnylam initiated the manufacturing shake-up after learning about issues at a separate third-party packaging facility it originally planned to use for the med’s launch, the company said.
The regulators’ observations weren’t directly tied to vutrisiran, nor has the FDA requested any extra clinical data on the med, Alnylam pointed out. Seeking to thwart potential delays to approval, Alnylam says it’s identified a new facility to pack and label the drug. The FDA is now due to make a decision on vutrisiran by July 14.
Vutrisiran is a follow-on candidate to Alnylam’s existing amyloid transthyretin (ATTR) amyloidosis med Onpattro, which could prove less cumbersome to patients thanks to its proposed under-the-skin dosing every three months. Onpattro, for its part, is given as an infusion every three weeks.
Evaluate Vantage has projected vutrisiran could snag $1.8 billion in 2026 sales.
“We are committed to working with the FDA and the new facility to bring this important treatment option as quickly as possible to patients living with the polyneuropathy of hATTR amyloidosis, an inherited, progressively debilitating, and fatal disease,” Pushkal Garg, M.D., chief medical officer and executive vice president for development and medical affairs at Alnylam, said in a statement. “We are confident in our regulatory application and the body of data supporting the efficacy and safety of vutrisiran.”
Aside from its FDA application, vutrisiran is up for review in the EU, Brazil and Japan, Alnylam pointed out.
“We aim to minimize the impact of this issue on these reviews through timely resolution of the matter or utilization of an alternative facility for one or more of these regions,” the company said.