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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.

Lilly currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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