Rhythm Pharmaceuticals (RYTM) on Sunday shared new results from a late-stage trial of its drug setmelanotide for acquired hypothalamic obesity, a rare condition that causes extreme weight gain and hunger.
The data showed that after 52 weeks, patients taking the drug saw their body mass index (BMI) drop by 16.4% on average. At the same time, patients on placebo saw their BMI rise by 2.4%.
The drug also reduced hunger, the company said. Patients aged 12 and older reported a 2.5-point drop in weekly hunger scores, compared with a 1.3-point drop in the placebo group, it said.
The new data includes additional patients from Japan, and others added beyond the main study group, according to the company.
The US FDA is reviewing the drug, with a Prescription Drug User Fee Act decision expected by March 20, Rhythm said.