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Lilly (LLY) Gets FDA Approval for Higher Doses of Trulicity
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Eli Lilly and Company ((LLY - Free Report) ) announced that the FDA granted approval to two higher doses, 3 mg and 4.5 mg, of its GLP-1 receptor agonist, Trulicity.
The approval was based on data from the AWARD-11 phase III study. The study demonstrated that the 3 mg and 4.5 mg doses of Trulicity led to superior reduction in A1C (a measure of blood glucose) and weight in type II diabetes patients compared to once-weekly Trulicity 1.5 mg dose, which is currently available.
36-week data from the study showed that 3 mg and 4.5 mg doses of Trulicity pen led to A1C reductions of 1.7% and 1.9%, respectively and weight reductions of 8.8 pounds and 10.4 pounds compared with 1.5% and 6.8 pounds for the 1.5 mg dose. The additional doses will be available from late September. A similar application to include data from the AWARD-11 study on Trulicity’s label is under review in the European Union.
Lilly’s shares have risen 13.4% this year so far compared with the industry’s increase of 2.0%.
Trulicity is a key drug in Lilly’s diabetes portfolio. In the first half of 2020, Trulicity generated revenues of $2.46 billion, up 29% year over year. Trulicity is the highest revenue generating product for Lilly.
However, Trulicity is facing stiff competition from Novo Nordisk’s (NVO - Free Report) Ozempic/semaglutide. 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 has increased. The class includes Lilly’s key diabetes medicine, Jardiance.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
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Lilly (LLY) Gets FDA Approval for Higher Doses of Trulicity
Eli Lilly and Company ((LLY - Free Report) ) announced that the FDA granted approval to two higher doses, 3 mg and 4.5 mg, of its GLP-1 receptor agonist, Trulicity.
The approval was based on data from the AWARD-11 phase III study. The study demonstrated that the 3 mg and 4.5 mg doses of Trulicity led to superior reduction in A1C (a measure of blood glucose) and weight in type II diabetes patients compared to once-weekly Trulicity 1.5 mg dose, which is currently available.
36-week data from the study showed that 3 mg and 4.5 mg doses of Trulicity pen led to A1C reductions of 1.7% and 1.9%, respectively and weight reductions of 8.8 pounds and 10.4 pounds compared with 1.5% and 6.8 pounds for the 1.5 mg dose. The additional doses will be available from late September. A similar application to include data from the AWARD-11 study on Trulicity’s label is under review in the European Union.
Lilly’s shares have risen 13.4% this year so far compared with the industry’s increase of 2.0%.
Trulicity is a key drug in Lilly’s diabetes portfolio. In the first half of 2020, Trulicity generated revenues of $2.46 billion, up 29% year over year. Trulicity is the highest revenue generating product for Lilly.
However, Trulicity is facing stiff competition from Novo Nordisk’s (NVO - Free Report) Ozempic/semaglutide. 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 has increased. 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.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
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