With a filing for US Food and Drug Administration (FDA) of migraine treatment Qtrypta (zolmitriptan) scheduled for next month, Zosana is putting in place the elements it will need to take the candidate through the approval process.
Zosana got a clearer picture of what lies ahead recently when it held a pre-new drug application (NDA) meeting with the FDA. Hayley Lewis, senior vice president, operations at Zosana, came away from the meeting confident that the manufacturing side of the filing is on track.
Lewis said, “We didn't identify any issues that we can see with some official or any of our contract manufacturers, actually, and the remaining steps that we have now, besides finalizing datasets for the NDA, is obviously ensuring that all of our contract manufacturers are ready to host pre-approval inspections when the time comes.”
At the pre-NDA meeting with the FDA, Zosana shared information about its chemistry, manufacturing and controls work and how it intends to manage scale up.
Zosana prepared for commercialisation of Qtrypta by transferring the production process over to a Thermo Fisher Scientific facility in North Carolina, US. Work to build out a commercial suite to support sales of Qtrypta is underway.
The work is adding to costs at Zosana, which cited “scale-up and technology transfer to our contract manufacturer” as a driver of the 16% year-on-year increase in R&D costs in the third quarter.
As part of the transfer to the contract manufacturing organisation (CMO), Zosana has performed a pharmacokinetic (PK) bridging study. The study showed the PK profiles of batches produced at Zosana’s facility in Fremont, California, are similar to those of products made by its CMO.
Zosana has also recently completed analysis of the 12-month stability of its registration batches. With that study and the pre-NDA meeting passing without incident, Zosana thinks it is on a path that will lead to approval of Qtrypta around the end of next year.
The timeline reflects the belief that the FDA will put the drug through its standard review process. Zosana thinks the product’s use of an intracutaneous microneedle system, a technology not yet used in any FDA-approved products, will ensure the agency performs a full, standard review of Qtrypta.