Rykindo

Psychiatry· 444 cited findings· 1 source document

Company: SHANDONG LUYE

What the regulatory reviews say

Rykindo (LY03004) is an injectable medication recommended for the treatment of schizophrenia in adults, and as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. The recommended dosing regimen is one injection every two weeks.

Efficacy findings from studies comparing LY03004 to a Listed Drug (LD) showed varying changes in PANSS total score from baseline. For LY03004, these changes ranged from -0.2 to -2.9, while for the Listed Drug, they ranged from -2.0 to -3.7. Oral supplementation duration for LY03004 was 2 weeks, and for the Listed Drug, it was 3 weeks. The safety profile of LY03004 was found to be similar to the Listed Drug, with no new safety signals identified. Two instances of ALT increase leading to discontinuation were observed with LY03004. While more subjects administered the Listed Drug had PK alerts (plasma concentrations of total active moiety above 120 ng/mL after a 50-mg dose), the absolute plasma concentration levels of total active moiety were higher with LY03004. The highest concentrations on the Listed Drug were almost 2-fold higher than LY03004. There was no indication of dose dumping with LY03004.

The regulatory action for NDA 212849 was an Approval, with a PDUFA Goal Date of January 14, 2023, and a Review Completion Date of January 13, 2023.

Key figures — cited to the source page

PANSS total score change from baseline (LY03004)	-2.9	SHANDONG LUYE — Rykindo FDA Review, p.208
PANSS total score change from baseline (Listed Drug)	-3.7	SHANDONG LUYE — Rykindo FDA Review, p.208
Oral supplementation duration for LY03004	2 weeks	SHANDONG LUYE — Rykindo FDA Review, p.57
Oral supplementation duration for LD	3 weeks	SHANDONG LUYE — Rykindo FDA Review, p.57
ALT increased (AE leading to discontinuation) on LY03004	2	SHANDONG LUYE — Rykindo FDA Review, p.79
Subjects breaching PK alert levels (> 120 ng/mL)	8 (LD) vs 5 (LY03004) subjects	SHANDONG LUYE — Rykindo FDA Review, p.25
Recommended Regulatory Action	Approval	SHANDONG LUYE — Rykindo FDA Review, p.2
Recommended Indication	Treatment of schizophrenia in adults; As monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults	SHANDONG LUYE — Rykindo FDA Review, p.2

Source documents

SHANDONG LUYE — Rykindo FDA Review (NDA212849, ORIG 1, 2023) (2023)

Explore the full evidence

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.