Novo Nordisk Withdraws Wegovy FDA Heart Failure Submission, Terminates Development Of Two Early Stage Assets

Earlier on Wednesday, Denmark’s most valuable company, Novo Nordisk A/S NVO, reported second-quarter earnings that missed the analyst consensus.

In its quarterly earnings presentation, Novo Nordisk said that in January 2024, it submitted the results from Wegovy STEP HFpEF trials for regulatory review in the US and EU.

Based on interactions with the FDA, the company has decided to withdraw the file. It expects to resubmit the file at the beginning of 2025 with additional relevant data, including data from the once-weekly injectable semaglutide 1.0 mg kidney outcomes trial.

The company conducted two HFpEF trials in patients with established HFpEF 1 in diabetes and one in patients without diabetes but with obesity. 

“When we did the meta-analysis of the two trials, we see a 69% decrease in risk of CV death or hospitalization for heart failure, so absolutely very strong data,” said Martin Holst Lange, Executive Vice President, Head of Development, in a conference call.

However, since the studies were “reasonably small,” Lange added that the FDA wanted to see an increase in the volume of events to substantiate the effect of treatment with semaglutide. 

In August 2023, Novo Nordisk announced results from the phase 3 STEP HFpEF trial of once-weekly semaglutide 2.4 mg in adults with heart failure with preserved ejection fraction (HFpEF).

In March, Wegovy was approved to reduce the risk of cardiovascular events in adults with established heart disease who are obese or overweight.

Due to portfolio considerations, Novo Nordisk terminated the development of Phase 1 once-monthly dual GLP-1/GIP receptor agonist and Phase 1 trial of VAP-1i in MASH.

Second quarter sales increased 25% to DKK 68.06 billion ($10.21 billion), slightly below the consensus of DKK 68.65 billion ($10.3 billion).

Ozempic sales reached DKK 28.9 billion ($4.3 billion), up 30% at constant currency. Wegovy revenues increased 53% to DKK 11.7 billion ($1.76 billion).

In the U.S., demand for Wegovy exceeds supply, and to safeguard continuity of care, the supply of the initiation dose strength remains capped. Wegovy has achieved broad commercial formulary access, with more than 200,000 weekly prescriptions and around 35,000 weekly new-to-brand prescriptions.

Total weekly prescriptions for Wegovy have around doubled compared to the beginning of the year.

Sales of Saxenda decreased by 19% to DKK 2.25 billion as the obesity care market is moving towards once-weekly treatments.

Novo Nordisk reported a second-quarter net income of DKK 4.49 per share, up 4% year over year, missing the consensus of DKK 5.05.

Price Action: NVO stock is down 7.73% at $120.07 at the last check on Wednesday.

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