Achieve Life Sciences Receives FDA Complete Response Letter for Cytisinicline
Achieve Life Sciences (ACHV) received a Complete Response Letter from the FDA for its cytisinicline smoking-cessation drug, with manufacturing and labeling issues rather than efficacy or safety concerns. The company targets Q4 2026 resubmission with Adare as manufacturing partner and potential approval by 1H2027.
Achieve Life Sciences () received a Complete Response Letter from the FDA regarding its New Drug Application for cytisinicline, a smoking-cessation therapy, citing manufacturing and labeling issues rather than concerns about the drug's efficacy or safety [1]. The regulatory action delays approval but leaves open a clear path to resubmission.
The CRL does not identify problems with cytisinicline's clinical performance in treating nicotine dependence, according to the company's assessment of the FDA feedback [1]. Instead, the agency's objections center on manufacturing processes and product labeling, issues the company views as addressable without additional clinical trials.
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