Drugs

Nicotine Dependence NDA Gets Complete Response Letter

FDA has issued Achieve Life Sciences a Complete Response Letter (CRL) on its NDA for cytisinicline as a treatment for nicotine dependence. “The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that was not completed by the FDA’s action date,” the company says, adding that the agency identified no deficiencies regarding the drug’s efficacy or safety.

The deficiencies cited in the CRL pertain to Achieve's prior third-party manufacturing facility, which received an Official Action Indicated classification from FDA for general GMP matters at the facility that are not specific to cytisinicline, according to the company.

Achieve had previously disclosed that the CRL was expected, and that it previously partnered with U.S.-based Adare Pharma Solutions as its new primary commercial manufacturing partner. It has completed the analytical method technology transfer to Adare’s facility, successfully manufactured its first cytisinicline engineering batch, and fully qualified all testing procedures at the site. Achieve intends to resubmit its NDA in the fourth quarter, naming Adare as its primary manufacturing partner, with potential FDA approval in the first half of 2027.

The NDA is supported by data from more than 1,500 clinical trial participants exposed to cytisinicline, according to the company. “In the pivotal Phase 3 ORCA-2 and ORCA-3 trials, cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater smoking abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo,” the company says.

Cytisinicline is described as a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. “It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products,” the company says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome