Eli Lilly's Trulicity Approved by FDA for Type II Diabetes
Eli Lilly and Company (LLY) received good news when the FDA approved its new injectable diabetes treatment, Trulicity, for adults suffering from type II diabetes.
Trulicity, a glucagon-like peptide-1 (GLP-1) receptor, has been approved as an adjunct to diet and exercise to improve glycemic control in type II diabetes patients.
However, Trulicity will carry a boxed warning regarding the increased risk of thyroid C-cell tumors based on studies in rats. We note that the treatment is under review in the EU.
The approval was based on a number of studies on Trulicity, used alone or in combination with commonly prescribed diabetes medications, including metformin, Actos, Amaryl and insulin Humalog.
The studies included five large phase III clinical trials under the Assessment of Weekly AdministRation of LY2189265 in Diabetes (:AWARD) development program. These studies compared Trulicity to four commonly used type II diabetes medicines: metformin, Januvia, Byetta and Lantus on the basis of efficacy.
Concurrently, Eli Lilly announced that results from the phase III trial, RAINBOW, on Cyramza in combination with paclitaxel in patients suffering from advanced gastric (stomach) cancer or gastroesophageal junction (:GEJ) adenocarcinoma were published in the online version of The Lancet Oncology.
The trial met its primary end point. Results showed that patients treated with Cyramza plus paclitaxel had a statistically significant improvement in median overall survival. The trial also met its secondary endpoints of progression-free survival and objective response rate.
Meanwhile, the animal health division of Eli Lilly, Elanco and Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company (DOW), have announced a strategic research and development (R&D) agreement to focus on developing integrated solutions to enable livestock producers to increase meat and milk production in order to meet the demands of the growing global population.
The approval of Trulicity will further boost Eli Lilly’s diabetes franchise which boasts of insulins like Humalog and Humulin and drugs like Tradjenta.
Eli Lilly is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Allergan Inc. (AGN) and Gilead Sciences, Inc. (GILD). Both carry a Zacks Rank #1 (Strong Buy).
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