Late Monday, the FDA approved a supplemental indication for bankrupt Vivus’ Qsymia (phentermine and topiramate) for chronic weight management in obese adolescents aged 12 and over, defined as adolescents with a classification of obesity index of 95th percentile and above. ..
First approved for adults in 2012, Vivus struggled to sell Qsymia, with first-quarter 2020 sales of less than $ 9 million, filing for bankruptcy later that year, and becoming a wholly owned subsidiary of Icahn Enterprises LP. Introduced in Chapter 11.
Despite these issues, the company still has this new indication for a drug that was once considered a market leader in the multi-billion dollar obesity sector.
Note that adolescent obesity has increased over the last 50 years and 21% of adolescents in the United States are now considered obesity, the FDA is a Vivus drug as long as it is increasing in addition to a low-calorie diet. Said that it became available for this young population of physical activity.
The extended label is based on a 56-week, double-blind, placebo-controlled trial of 223 people aged 12 to <17 years with a BMI of the 95th percentile or higher by age and gender. Participants who received two doses of Qsymia (7.5 mg / 46 mg and 15 mg / 92 mg) lost an average of 4.8% and 7.1% of BMI, respectively, whereas individuals who received placebo averaged BMI. I got 3.3%. The FDA said.
However, the FDA also warned that taking Qsymia during pregnancy could be harmful to the fetus, including an increased risk of cleft lip and palate.
“Patients of childbearing potential should obtain a negative pregnancy test before starting Qsymia treatment, perform a monthly pregnancy test, and provide effective contraception while taking Qsymia. I recommend it, “said the FDA.
The agency previously called the company 2019 letter After Vivus suggested misunderstanding, Qsymia suggested that patients could help them lose weight three times faster than diet and exercise alone. The agency also explained how the company presented patient data from a particular point in time during a clinical trial of only those who remained in Qsymia.
“According to the CLINICAL STUDIES section of PI, a significant proportion of patients withdrew from study before the end of study at week 56. 40% in study 1 and 31% in study 2. Withdrawal from study. Explain these patients who have been treated. By selectively presenting the results without this contextual information, the presentation exaggerates the effectiveness of the product and is misleading, so that all patients who have undergone Qsymia are treated. It means we continued, “added the agency.
Meanwhile, a generic version of the weight loss drug is coming. In 2017, Vivus signed two contracts with Teva’s Actavis and Dr. Reddy. This will allow generics of Qsymia to enter the market from December 2024 and 2025.