Achieve Life says FDA advises on need for long-term cytisinicline exposure data

In a regulatory filing yesterday, Achieve Life Sciences stated: “As previously reported, Achieve Life Sciences recently conducted a pre-New Drug Application, or ‘NDA,’ meeting with the U.S. Food and Drug Administration for the company’s drug product candidate, cytisinicline, during which agreement was reached on many of the submission requirements for an NDA. During that meeting, the FDA expressed support for an NDA submission based on adequate data to assess efficacy from the two randomized and controlled Phase 3 trials. In addition, the FDA advised that long-term exposure data beyond 12 weeks would be needed to adequately assess safety risk given that it views smoking cessation drugs as products for chronic, intermittent use because patients may relapse and require subsequent courses of treatment over a lifetime. The FDA advised that long-term safety data could be collected on a patient’s cumulative treatment over time and could also be collected in the vaping cessation program. The company is participating in ongoing discussions with the FDA to clarify the requirements and timing for the long-term exposure safety data to support an NDA submission and the company’s NDA filing timing may be delayed to address this FDA feedback. Following receipt of additional input from the FDA, anticipated in the first quarter of 2024, the company will provide an update on its projected NDA submission timing.”