Eli Lilly & Company LLY recently announced that the FDA has approved the inclusion of cardiovascular (CV) risk reduction data from the EMPA-REG OUTCOME study on the labels of three type 2 diabetes medicines belonging to the Jardiance family – Synjardy, Synjardy XR and Glyxambi.
The data have been added to the "Clinical Studies" sections of the Prescribing Information of the three drugs which Lilly markets in collaboration with German drugmaker, Boehringer Ingelheim.
Lilly’s share price rose 1.6% so far this month, marginally better than an increase 1% for the Zacks-classified Large-Cap Pharma industry. However, last year, Lilly’s shares underperformed the broader industry due to soft earnings results and some negative pipeline updates, including the failure of its high-profile investigational Alzheimer’s disease drug, solanezumab. As a result, shares declined 12.7%, compared to a 5.5% fall for the industry.
Coming back to the latest news, the approval comes less than a month after the FDA approved the inclusion of CV risk reduction data from the aforementioned study in Jardiance’s label. While Synjardy is a combination of Jardiance and metformin hydrochloride, Synjardy XR is an extended release version of Synjardy. Meanwhile, Glyxambi is a Jardiance/Tradjenta combination tablet.
Jardiance is approved for lowering blood sugar in adults with type 2 diabetes. In early December, the FDA further approved the drug for reducing the risk of cardiovascular death in adults with type II diabetes. With about 50% of the deaths in type II diabetics across the world resulting from the CV disease, addition of this data to Jardiance’s label is expected to significantly bolster sales of the drug. Jardiance recorded sales of $47.5 million in the third quarter of 2016.
The landmark EMPA-REG OUTCOME trial showed that irrespective of the type of cardiovascular disease at baseline, Jardiance tablets reduced the risk of cardiovascular death in adults with type II diabetes and established cardiovascular disease, compared to placebo plus standard of care.
The study was conducted in more than 7,000 patients from 42 countries with type II diabetes and cardiovascular disease. It has been regarded as the first long-term trial on a diabetes medication to show a reduction in cardiovascular death in adults with type II diabetes and established cardiovascular disease.
However, the effectiveness of Synjardy, Synjardy XR and Glyxambi in reducing the risk of cardiovascular deaths in such patients was not established by the study.
These label updates are expected to give Lilly a competitive advantage over the other oral type II diabetes medicine manufacturers. The diabetes market is already quite crowded given the presence of companies like Novo Nordisk A/S NVO, Johnson & Johnson JNJ and Merck & Co. Inc. MRK.
Lilly carries 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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