Nov. 4 at 6:52 PM
$XXII Achieve Life Sciences' (ACHV) cytisinicline is considered a potential improved smoking cessation drug successor to Chantix (varenicline) , Chantix annual global sales peaked at
$1.4 billion in 2010. The drug quickly became a blockbuster for Pfizer. Cytisinicline would be the first new FDA-approved prescription treatment option for smoking cessation in nearly 20 years, filling a significant gap in the market.
Studies supported by researchers from Massachusetts General Hospital (MGH) have shown that the smoking cessation drug cytisinicline has a favorable tolerability profile compared to Chantix.
The U.S. Food and Drug Administration (FDA) has set a PDUFA target action date of June 20, 2026 (target date when the FDA intends to make an approval decision), for its New Drug Application.
Pending FDA approval, a commercial launch in the U.S. is expected in the second half of 2026.
Vaping Cessation: ACHV has a rare FDA Commissioner's National Priority Vocher.
