Johnson & Johnson Files SNDA For Label Expansion Of Invokana

Johnson & Johnson’s (NYSE:JNJ) announced that it has submitted a supplemental new drug application (sNDA) to the FDA for the label expansion of its diabetes drug Invokana (to include the cardiovascular indication based on data from a large CANVAS outcomes program.

The application, to include the indication of risk reduction of cardiovascular events in type II diabetes patients, also applies to Invokana’s fixed-dose combinations, Invokamet and Invokamet XR.

The filing was based on data from the CANVAS Program which evaluated Invokana- a SGLT2 inhibitor compared with placebo on CV events in type II diabetes patients who have established cardiovascular (CV) disease or are at risk for CV disease. The primary endpoint of the study was defined as major adverse cardiovascular events (MACE), which included CV death, nonfatal myocardial infarction and nonfatal stroke. The study showed that Invokana was successful in reducing the risks of heart attacks and strokes. The CANVAS program comprised two, nearly-identical large outcomes studies called CANVAS and CANVAS-R. However, the study also showed that the drug increased the risk of amputations.

So far this year, Johnson & Johnson’s share price has increased 14.7% comparing unfavorably with a gain of 17.6% recorded by the industry it belongs to.

Many pharma companies are working hard to get the labels of their diabetes medicines updated to include their cardiovascular benefits. With death from cardiovascular diseases being significantly higher in adults with diabetes compared to those without diabetes, the addition of positive CV outcomes on labels of diabetes drugs can give sales a shot in the arm.

Eli Lilly & Company (NYSE:LLY) received FDA approval last year to include CV risk reduction data from the EMPA-REG OUTCOME study on the label of Jardiance. The updated label including the cardiovascular indication was launched in Jan 2017 while the American Diabetes Association (ADA) has also updated its diabetes treatment guidelines. The European Commission also approved the Jardiance label update for the cardiovascular indication in 2016.

In August 2017, Novo Nordisk’s (NYSE:NVO) Victoza (liraglutide) was approved by the FDA for a new indication to reduce the risk of major adverse cardiovascular (CV) events in adults with type II diabetes and established CV disease. The FDA's decision was based on the results from the landmark LEADER trial, which demonstrated that Victoza statistically significantly reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 13% versus placebo, when added to standard of care, with an absolute risk reduction of 1.9%.

However, in May, Merck & Co., Inc. (NYSE:MRK) was denied approval by the FDA to include cardiovascular outcomes data from the TECOS study on the labels of its DPP-IV inhibitor Januvia (sitagliptin) and other medicines containing Januvia.

AstraZeneca’s Bydureon also failed to reduce cardiovascular risk in a phase IIIb/IV cardiovascular outcomes study, EXSCEL.

Johnson & Johnson Price

Johnson & Johnson carries a Zacks Rank #4 (Sell).

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