Epilepsy, Benign Neonatal

The FDA is taking issue with a promotional website from Taiho Oncology, alleging it misleadingly describes the benefits of its bile duct cancer drug Lytgobi, which won accelerated approval in 2022. The untitled letter sent last week calls out the way the company’s website offers allegedly misleading interpretations of efficacy in the single-arm trial on which the accelerated approval was based. The agency said certain efficacy-related parts of the webpage misbrand Lytgobi “by misleadingly suggesting that FOENIX-CCA2,” a Phase 1/2 study in 103 patients , “provided interpretable results regarding the effects of Lytgobi on PFS [progression-free survival] and OS [overall survival] endpoints.” Because FOENIX-CCA2 was designed as a single-arm trial, with no comparator arm, the FDA added, “the reported PFS and OS results are uninterpretable; absent an appropriate comparator, it is not possible to determine if the observed effect is attributable to Lytgobi or to other factor(s), such as the natural history of the disease.” The FDA acknowledged that Taiho said the data presented on its site should be interpreted with caution, but noted that such statements do “not render the promotional communication nonmisleading in light of the issues with FOENIX-CCA2.” Presentations on the website are also “misleading by suggesting that Lytgobi improves DCR [disease control rate] in patients with locally advanced or metastatic iCCA [intrahepatic cholangiocarcinoma] based on a composite of complete response (CR), partial response (PR), and stable disease (SD) when the study from which the presentations were drawn could not demonstrate this result,” the agency said. In a statement to Endpoints News , Taiho said it worked to present data “in a manner that is truthful and not misleading and consistent with FDA guidelines” and was “reviewing their comments and will respond appropriately and in a timely manner.” This is the second untitled letter this year from the FDA’s Office of Prescription Drug Promotion to industry.

MONDAY, Feb. 24, 2025 -- The highest risk for epilepsy after neonatal seizures appears to be within the first year of life, according to a study published online Feb. 19 in Developmental Medicine & Child Neurology. Jeanette Tinggaard, Ph.D., from Copenhagen University Hospital in Denmark, and colleagues estimated the cumulative risk for epilepsy after neonatal seizures and identified subpopulations at increased risk in a register-based cohort study involving all children born in Denmark between 1997 and 2018. A total of 1,294,377 children were followed, and 1,998 neonatal survivors of neonatal seizures were identified. The researchers found that the cumulative risk for epilepsy was 20.4 and 1.15 percent among children with and without neonatal seizures, respectively. Among children with neonatal seizures, epilepsy was diagnosed before 1 year of age in 11.4 percent, between 1 and 5 years in 4.5 percent, between 5 and 10 years in 3.1 percent, and between 10 and 22 years in 1.4 percent. Compared with children with seizures of unknown etiology, the etiologies of cerebral infarction, hemorrhage, or malformations and low Apgar score were associated with the highest risk for epilepsy (adjusted hazard ratios, 2.49 and 1.49, respectively). "Our study confirms a substantial risk of epilepsy after neonatal seizures in neonatal survivors, with the highest risk observed in the first year of life but persisting into adolescence," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

MONDAY, Feb. 24, 2025 -- A baby’s seizure in a neonatal ICU could be a red flag for future risk of epilepsy . Newborns who suffer seizures following birth are more likely to develop epilepsy in childhood and young adulthood, a new study suggests. More than 20% of newborns who have seizures wind up developing epilepsy by age 22, compared with a little over 1% of newborns without seizures, Danish researchers found. “The risk of epilepsy was highest in the first year of life but remained significantly elevated throughout childhood and adolescence,” noted the research team led by Dr. Jeanette Tinggaard , a child neurologist with Copenhagen University Hospital – Risghospitalet. In epilepsy, groups of damaged nerve cells in the brain sometimes generate abnormal and excessive electrical signals, resulting in seizures, according to the National Institutes of Health (NIH). Seizures are one of the most frequent neurological conditions among babies placed in a NICU, researchers said in background notes. As many as 1 to 5 cases occur for every 1,000 live births. For this study, researchers analyzed medical data for all children born in Denmark between 1997 and 2018, nearly 1.3 million children total. Of those, almost 2,000 children who grew to adulthood had suffered at least one bout of seizures as a newborn, researchers found. About 11% of newborns that had a seizure were diagnosed with epilepsy before 1 year old, and nearly 5% between ages 1 and 5. About 3% were diagnosed with epilepsy between ages 5 and 10, and more than 1% between 10 and 22. The risk of future epilepsy was more than doubled in newborns that had another brain condition alongside their seizures, including stroke, brain bleeding or structural brain malformations, researchers found. Babies with seizures also were about 50% more likely to develop epilepsy if they had a low Apgar score – a quick assessment of their health immediately after birth based on appearance, pulse, grimace, activity and respiration. Since not all newborns who suffer seizures develop epilepsy, it’s likely that genetics or some other risk factor also is at play in these cases, Tinggaard said. “Importantly, four out of five neonatal survivors with a history of neonatal seizures did not develop epilepsy, and we suggest future studies to explore a potential genetic predisposition,” Tinggaard concluded. The new study appears in the journal Developmental Medicine & Child Neurology . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.