- Novo Nordisk A/S NVO announced headline results from the PIONEER PLUS phase 3b trial of oral semaglutide 25 mg and 50 mg as an add-on to a stable dose of 1–3 oral antidiabetic medicines in type 2 diabetes patients.
- When evaluating the effects of treatment taken as intended and from a mean baseline HbA1c of 9.0 %, 25 mg and 50 mg oral semaglutide achieved an HbA1c reduction of 1.9 and 2.2 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg.
- From a mean baseline body weight of 96.4 kg, oral semaglutide 25 mg and 50 mg experienced a statistically significant higher weight loss of 7.0 kg and 9.2 kg, respectively, compared with a reduction of 4.5 kg with oral semaglutide 14 mg.
- Related: Novo Nordisk Suspended From UK Trade Association For Practice Breaches.
- When applying the treatment policy estimand, 25 mg and 50 mg oral semaglutide achieved an HbA1c reduction of 1.8 and 2.0 percentage points, respectively, compared with a reduction of 1.5 percentage points with oral semaglutide 14 mg.
- Weight loss of 6.7 kg and 8.0 kg for semaglutide 25 mg and 50 mg, respectively, compared with a reduction of 4.4 kg at 14 mg dose strength.
- All doses of oral semaglutide appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal. The vast majority were mild to moderate.
- Novo Nordisk expects to file for regulatory approvals in the U.S. and the EU in 2023.
- The global roll-out of the 25 and 50 mg doses is contingent on portfolio prioritisations and manufacturing capacity.
- Price Action: NVO shares are up 2.60% at $152.25 on the last check Friday.
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