Mallinckrodt becomes the latest victim of the FDA's pandemic-related delays as it pushes off application for skin graft
With Covid-19 locking down travel across the world, not even drug safety regulators have been spared from costly delays. For the FDA, whose inspection schedule keeps the trains on time for new marketing approvals, those delays are continuing to prove costly.
The FDA has pushed review of Mallinckrodt’s allogeneic skin graft for burns, dubbed StrataGraft, after the agency admitted it wasn’t able to conduct a plant inspection in the needed timeframe for a decision, the drugmaker said last week.
Mallinckrodt tied the delay to “Covid-19 travel restrictions” and said it had no hang-ups about its graft’s chances at an approval.
“We are confident in the efficacy and safety of StrataGraft for the treatment of deep partial-thickness burns based on our pivotal Phase 3 clinical trial results,” CSO Steven Romano said in a release. “We plan to work closely with the FDA to complete the review and schedule its site inspection.”
With the pandemic continuing to rage, the FDA has been forced to prioritize planned inspections for new drug applications. Often, that system has favored drugmakers with new molecules with a high clinical need and shoved to the side lower-importance products, particularly in aesthetics.
In late November, the FDA delayed its review of Revance’s frown-line injection daxibotulinumtoxinA, saying it didn’t have enough time to look over its Newark, California, manufacturing facility on time. In October, the agency pushed back Spectrum’s neutropenia candidate Rolontis after officials twice delayed a plant inspection of South Korea’s Hanmi, which holds the drug’s license.
Meanwhile, inspection delays have also nixed timely approvals for bigger-name products as well. The FDA repeatedly delayed a site inspection for Bristol Myers Squibb’s liso-cel, eventually conducting a site visit at Lonza Houston’s contract site in December that resulted in a Form 483. That delay pushed liso-cel’s approval past the Dec. 31 cutoff point tied to a $9 CVR investors held from Bristol’s acquisition of Celgene.
Lonza after the fact said the FDA’s delays didn’t give either company enough time to address any particular manufacturing issues, which are quite common for CAR-Ts on the whole. Liso-cel was eventually approved earlier this month and will be marketed as Breyanzi.