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Pharmaceutical industry

FDA Approves Novo Nordisk's Diabetes Drug Tresiba, Ryzodeg Injection

Strategic Insights

— 2 min read

The US Food and Drug Administration (FDA) has given the green light to Novo Nordisk's diabetes drug Tresiba, a long-acting insulin that can reduce the frequency of shots for people with type 1 and 2 diabetes. The approval comes after two years of rejections, with the agency initially asking for more information on the risks of heart problems associated with the drug's use. Tresiba, which is already available in 30 countries, is expected to generate significant sales, with analysts forecasting $2.4 billion in annual revenue by 2020. The FDA's approval of Tresiba is expected to have a positive impact on Novo Nordisk's stock price, with senior analyst Soren Lontoft Hansen predicting a 5-10% increase in the company's shares.

Key Takeaways:

  • The FDA has approved Tresiba, a long-acting insulin drug developed by Novo Nordisk, for the treatment of type 1 and 2 diabetes.
  • The approval comes after two years of rejections, with the agency initially asking for more information on the risks of heart problems associated with the drug's use.
  • Tresiba, which is already available in 30 countries, is expected to generate significant sales, with analysts forecasting $2.4 billion in annual revenue by 2020.
  • The FDA's approval of Tresiba is expected to have a positive impact on Novo Nordisk's stock price, with senior analyst Soren Lontoft Hansen predicting a 5-10% increase in the company's shares.
  • Tresiba can reduce the frequency of shots for people with diabetes, with some patients potentially going 42 hours between doses, compared to 18-24 hours for current long-acting insulins.
  • Novo Nordisk is planning to launch Tresiba in the United States in the first quarter of 2020.
  • The U.S. market for basal insulin represents over 80% of the global market, according to Soren Lontoft Hansen, senior analyst at brokerage firm Sydbank.
  • Novo Nordisk is a Danish multinational pharmaceutical company with production facilities in seven countries and affiliates or offices in 75 countries.

Statistics:

  • $2.4 billion: Analysts' forecasted annual sales of Tresiba by 2020 (Thomson Reuters Cortellis)
  • 5-10%: Predicted price reaction in Novo Nordisk's shares on Monday, according to Soren Lontoft Hansen, senior analyst at Sydbank
  • 42 hours: Potential gap between doses for diabetics using Tresiba, compared to 18-24 hours for current long-acting insulins
  • 80%: Proportion of the global market represented by the U.S. market for basal insulin, according to Soren Lontoft Hansen, senior analyst at Sydbank

Sources:

  • [Thomson Reuters Cortellis]
  • [Soren Lontoft Hansen, senior analyst at Sydbank]
  • [Todd Hobbs, chief medical officer for Novo Nordisk in North America]
  • [Novo Nordisk]
  • [FDA]

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