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Home Lilly's Trulicity Reduces Cardiovascular Events by 12% in ADA2019 REWIND Trial—Can It Outperform Semaglutide?

Lilly's Trulicity Reduces Cardiovascular Events by 12% in ADA2019 REWIND Trial—Can It Outperform Semaglutide?

Jun 11, 2019 08:31 CST Updated 08:31
Eli Lilly

Global Pharmaceutical R&D and Production Company

FDA

U.S. Food and Drug Administration

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

American Diabetes Association

Founded in 1940, the American Diabetes Association (ADA) is a premier voluntary health organization in the United States dedicated to supporting diabetes research and providing diabetes-related information services. Over the past 60 years, the Association has supplied extensive comprehensive information on diabetes to patients and healthcare professionals specializing in diabetes care. It has published an authoritative and practically valuable series of publications covering a wide range of topics, including medical guidelines, healthcare guidance, lifestyle and dietary recommendations, medications, recipes, cooking and nutrition, self-care, diabetes complications, and women and diabetes.

On June 9, Eli Lilly announced the results of the cardiovascular outcomes trial for Trulicity (dulaglutide) at the 2019 American Diabetes Association Scientific Sessions (ADA 2019). The data showed that in the REWIND study, Trulicity reduced the risk of heart attack, stroke, and cardiovascular death by 12% in patients with type 2 diabetes.

 

Trulicity is a subcutaneously injected glucagon-like peptide-1 (GLP-1) receptor agonist, approved by the FDA and EMA in September and November 2014, respectively, for the treatment of type 2 diabetes. Its sales revenue in 2018 amounted to $3.199 billion.

 

Trulicity’s strongest competitor is semaglutide, developed by Novo Nordisk and approved by the FDA in December 2017. As early as 2016, it was demonstrated to reduce the risk of cardiovascular events by 26%. In 2018, semaglutide achieved sales of $272 million. The new drug application for oral semaglutide was formally submitted to the FDA in March 2019.

 

However, there are some differences in the cardiovascular outcome studies of dulaglutide and semaglutide. First, 69% of the enrolled patients in the REWIND trial had no prior history of cardiovascular disease; second, the average follow-up period in the REWIND study reached 5.4 years, making it the longest-followed cardiovascular outcome trial to date; finally, the ratio of male to female participants was balanced, and this balance was consistent across each subgroup. Brad Woodward, Global Head of Development for Eli Lilly’s incretin-based products, stated, “This patient population is more representative of the type 2 diabetes patients commonly seen in clinical practice.”

 

Nevertheless, Eli Lilly is simultaneously developing another candidate product, tirzepatide, which has the potential to profoundly disrupt the GLP-1 market. Tirzepatide is a dual GIP/GLP-1 receptor agonist. At the 2019 American Diabetes Association (ADA) Scientific Sessions, Eli Lilly presented positive data on this drug, reinforcing its potential to reduce glycated hemoglobin (HbA1c) levels and body weight in patients with type 2 diabetes. Meanwhile, early studies have also demonstrated the potential benefits of tirzepatide in treating other metabolic disorders.

 

Analyst Kapadia believes that Eli Lilly will ultimately capture the largest market share of GLP-1 injectables, while Novo Nordisk’s oral semaglutide will significantly expand the market size of GLP-1 drugs.

 

References:

Fiercepharma：Lilly's Trulicity cuts heart risks by 12%. Is it enough to fend offsemaglutide?