Item 8.01 Other Events
The Company is providing the following business updates:
•The Company has submitted to the U.S. Food and Drug Administration ("FDA") the
second part of its New Drug Application ("NDA") for avacincaptad pegol ("ACP")
for the treatment of geographic atrophy ("GA") secondary to age-related macular
degeneration ("AMD"). Consistent with the Company's agreement with the FDA for
rolling NDA review, the Company previously submitted the first part of its NDA
on November 3, 2022, which included the full ACP clinical data package from the
GATHER1 and GATHER2 clinical trials. The recently submitted second part of the
NDA included nonclinical data. The remaining, final part of the NDA will include
chemistry, manufacturing and controls data. The Company remains on track to
complete the submission of its NDA to the FDA by the end of 2022.
•Based on formal feedback received from the FDA, the Company intends to pursue
further discussions with the FDA about utilizing the GATHER1 and GATHER2
clinical trial data included in the current NDA submission to support treatment
of GA associated with earlier stage disease, including in patients with
intermediate AMD ("iAMD"). As a result of these ongoing discussions, the Company
does not believe it needs to conduct a new clinical trial of ACP in patients
with iAMD.
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