Pfizer Ireland Pharmaceuticals: MOD-4023

Health Service Act for MOD-4023 injection.

We acknowledge receipt of your major amendment dated September 15, 2021, which extended the goal date by three months.

MOD-4023-treated subjects were ADA-positive compared to 16% of Genotropintreated subjects.

There are insufficient follow up data to determine whether the reduction in AHV in this patient was caused by immunogenicity, and we consider attenuation of effectiveness due to immunogenicity to be a potential risk at this time.

Given the availability of other hGH replacement therapies that have similar efficacy and that do not carry this risk, MOD-4023 does not appear to address any identifiable unmet need that would justify its approval in light of this uncertainty, and we have concluded that the benefit-risk profile for MOD-4023 is unfavorable at this time.

At a minimum, provide data to show that ADA (including neutralizing antibodies) meaningfully decrease or resolve with MOD-4023 discontinuation and/or changing patients to other approved hGH formulations.

Inspections of the Pfizer Ireland Pharmaceuticals, Dublin, Ireland (FEI: 3004145594) and Pfizer Manufacturing Belgium NV (FEI: 1000654629) facilities are required before this application can be approved as the FDA must assess the ability of those facilities to conduct the listed manufacturing operations in compliance with CGMP.

You may respond to the other deficiencies in this Complete Response letter while the travel restrictions remain in effect.

However, even if all other deficiencies are addressed, the application cannot be approved until the required FDA inspections are completed and the findings are assessed with regard to your application.

(13) Provide any updated batch analysis data for DS and DPS and DP (prefilled pen) as applicable for batches released since your original BLA submission.