Oral semaglutide in the PIONEER program
On February 22, 2018, Novo Nordisk (NVO) announced the results of its 26-week Phase 3a trial, PIONEER 1, which evaluated the efficacy of oral semaglutide as a treatment option for type 2 diabetes patients in three different daily dosages: 3 mg, 7 mg, and 14 mg.
The investigational therapy demonstrated a statistically significant improvement in blood glucose levels compared to the placebo irrespective of the treatment adherence rates of the patients. However, it was only for the 14 mg dosage of oral semaglutide that the therapy demonstrated a statistically significant reduction in weight for patients. In cases where patients adhered to the treatment regimen properly, all oral semaglutide dosages demonstrated a robust drop in both the blood glucose levels and body weights of the patients.
The above diagram shows the anticipated timeline for the data readouts from various trials in the PIONEER program and for the filing of the regulatory application for oral semaglutide in diabetes indications.
Saxenda’s growth prospects
On December 23, 2014, that FDA approved Saxenda for reducing appetite in patients suffering from obesity. In April 2017, the FDA updated Saxenda’s label and added data highlighting the long-term efficacy and safety of Saxenda in weight management.
In June 2017, the Committee for Medicinal Products for Human Use (or CHMP) recommended that Saxenda’s label be updated to include data from the LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) trial, which highlighted the cardiovascular risk-reduction benefits of the drug. Novo Nordisk is currently awaiting the FDA’s decision to add the LEADER data to Saxenda’s label in the United States.