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Lilly's Study on Higher Doses of Trulicity Meets Endpoint
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Eli Lilly and Company’s (LLY - Free Report) phase III study evaluating higher doses of its GLP-1 receptor agonist, Trulicity, demonstrated superiority in A1C (a measure of blood glucose) reduction in type II diabetes patients compared to Trulicity doses already available
Data from AWARD-11 phase III study showed that 3.0 mg and 4.5 mg doses of Trulicity significantly reduced A1C from baseline compared to once-weekly Trulicity 1.5 mg after 36 weeks, thereby meeting the study’s primary efficacy endpoint of superiority. The study also demonstrated superiority in weight loss, its secondary efficacy endpoint.
The study will continue for 52 weeks and Lilly plans to file for regulatory approval of the higher doses by late 2019.
Lilly’s shares have declined 3.8% this year so far compared with the industry’s increase of 3.3%.
Trulicity is a key drug in Lilly’s diabetes portfolio. In the first quarter of 2019, Trulicity generated revenues of $879.7 million, up 30% year over year driven by higher demand in the United States and higher volumes in ex-U.S. markets, which offset the impact of lower realized prices.
However, Trulicity is facing stiff competition from Novo Nordisk’s (NVO - Free Report) Ozempic/semaglutide, launched in 2018. In fact, Lilly is seeing pricing pressure across all its diabetes products, which creates uncertainty around the franchise’s long-term growth prospects. A number of competitors are entering the diabetes space. For example, with the approval of Merck (MRK - Free Report) /Pfizer’s (PFE - Free Report) Steglatro and its combinations, competition in the SGLT2 inhibitors class is expected to increase. The class includes Lilly’s key diabetes medicine, Jardiance.
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Lilly's Study on Higher Doses of Trulicity Meets Endpoint
Eli Lilly and Company’s (LLY - Free Report) phase III study evaluating higher doses of its GLP-1 receptor agonist, Trulicity, demonstrated superiority in A1C (a measure of blood glucose) reduction in type II diabetes patients compared to Trulicity doses already available
Data from AWARD-11 phase III study showed that 3.0 mg and 4.5 mg doses of Trulicity significantly reduced A1C from baseline compared to once-weekly Trulicity 1.5 mg after 36 weeks, thereby meeting the study’s primary efficacy endpoint of superiority. The study also demonstrated superiority in weight loss, its secondary efficacy endpoint.
The study will continue for 52 weeks and Lilly plans to file for regulatory approval of the higher doses by late 2019.
Lilly’s shares have declined 3.8% this year so far compared with the industry’s increase of 3.3%.
Trulicity is a key drug in Lilly’s diabetes portfolio. In the first quarter of 2019, Trulicity generated revenues of $879.7 million, up 30% year over year driven by higher demand in the United States and higher volumes in ex-U.S. markets, which offset the impact of lower realized prices.
However, Trulicity is facing stiff competition from Novo Nordisk’s (NVO - Free Report) Ozempic/semaglutide, launched in 2018. In fact, Lilly is seeing pricing pressure across all its diabetes products, which creates uncertainty around the franchise’s long-term growth prospects. A number of competitors are entering the diabetes space. For example, with the approval of Merck (MRK - Free Report) /Pfizer’s (PFE - Free Report) Steglatro and its combinations, competition in the SGLT2 inhibitors class is expected to increase. The class includes Lilly’s key diabetes medicine, Jardiance.
Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
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