REGULATORY SUBMISSION SUMMARY (excerpt)
NDA 224-567 — XYLEVA (halomectinib)
--- SYNTHETIC DEMONSTRATION DOCUMENT — NOT A REAL FDA NDA SUMMARY ---

Submission Metadata
Submission Type: New Drug Application (NDA)
Submission Number: NDA-224567
Submitting Sponsor: Halcyon Bio Corp
Reviewing Regulator: U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)
Submitted: August 1, 2022
Decision: APPROVED
Decision Date: May 12, 2023
Approval Pathway: Standard Review
Pediatric Assessment: Waived (deferred under PREA; adult-only initial indication)

Product Covered
XYLEVA (halomectinib) 25 mg and 50 mg tablets
Sponsor development code: HB-207
Modality: Small molecule
Proposed Indication (at submission): Type 2 diabetes mellitus in adults, as an adjunct to
diet and exercise (approved as filed).

Pivotal Clinical Program Cited
Two Phase 3 trials formed the basis of approval:
    NCT8888321 (XYLEVA-101) — Halcyon Bio-sponsored Phase 3, 1,204 randomized adults, 26-week
    A1C reduction primary endpoint. Sponsor: Halcyon Bio Corp. Coordinating PI: Miguel Estrada,
    M.D. (Cleveland Clinic).
    NCT8888322 (XYLEVA-102) — Halcyon Bio-sponsored Phase 3, 998 randomized adults, 52-week
    durability endpoint. Sponsor: Halcyon Bio Corp.

Manufacturing Coverage
Drug substance manufactured at: Halcyon Bio Corp — Andover, Massachusetts (FEI 3009123456).
Drug product manufactured at: Meridian Biopharm, Inc. — Bedford, Massachusetts (FEI 3009654321;
contract manufacturer).

Post-Approval Supplemental Submissions
    sNDA-224567/S-001  Submitted 2023-11-20, approved 2024-03-15 — labeling update
    (revised warnings section — pancreatitis language)
    sNDA-224567/S-002  Submitted 2024-04-08, approved 2024-09-12 — manufacturing supplement
    (addition of secondary drug-product site)
    sNDA-224567/S-003  Submitted 2024-08-05, under review — geriatric-use labeling update
