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J&J's (JNJ) Invokana Label Expansion Filing Hit by FDA Delay

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J&J's (JNJ) Invokana Label Expansion Filing Hit by FDA Delay

The FDA defers decision regarding label expansion application to include cardiovascular indication on the label of J&J's (JNJ) diabetes drug Invokana.

Johnson & Johnson JNJ announced that the FDA has extended the review timeline for a supplemental new drug application (sNDA) with respect to its SGLT2 inhibitor, Invokana. The sNDA seeks the regulatory body’s approval for a new indication of risk reduction of cardiovascular events in type II diabetes patients at a risk of cardiovascular (CV) disease.

The application, also applying to Invokana’s fixed-dose combinations — Invokamet and Invokamet XR — is based on data from the phase III study CANVAS.

Data from the CANVAS CV OUTCOMES study, presented last year, showed that Invokana reduced major adverse CV events or major adverse cardiovascular events (MACE) by 14% in comparison to placebo in diabetes patients, who are at risk or with a history of CV disease. MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke.

While the risk of CV death was lowered by 13%, that of nonfatal MI and nonfatal stroke was decreased by 15% and 10%, respectively. The data also showed that Invokana curbed risk for hospitalization due to heart failure (HHF).Meanwhile, the study also demonstrated the CV safety of Invokana and its superiority compared with placebo.

However, an increased risk of amputations was identified in both studies, which was almost double as compared to placebo’s case. This observation was consistent with the black boxed warning on Invokana’s label on the increased amputation peril associated with the use of the drug.

The FDA has requested a three-month extension to provide additional time to complete the application’s review. The sNDA was submitted last October. Following the latest postponement, the action date is now set in October this year.

In first-quarter 2018, Invokana sales declined 12.7% to $248 million due to higher managed care discounting and lower market share, thanks to competitive pressure. If approved for the cardiovascular indication, the drug’s sales should pick up.

So far this year, Johnson & Johnson’s share price has decreased 9.8%, comparing unfavorably with the industry’s decline of 0.9%.


Notably, many pharma companies are working hard to get their diabetes medicines’ labels updated to include cardiovascular benefits. With death toll from cardiovascular diseases significantly rising among adult diabetic patients compared with those without the disease, the addition of positive CV outcomes on diabetes drugs’ labels can thus give sales a shot in the arm.

We would like to remind investors that in 2016, Eli Lilly & Company LLY received the European Commission and FDA nods to include CV risk reduction data from the EMPA-REG OUTCOME study on the label of its SGLT2 inhibitor, Jardiance. The updated label including the cardiovascular indication was launched last January and is pushing up the drug’s sales.

Johnson & Johnson carries a Zacks Rank #3 (Hold). Better-ranked stocks in the pharma sector include Vanda Pharmaceuticals Inc. VNDA and Genomic Health Inc GHDX, both sporting a Zacks Rank #1 (Strong Buy).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Vanda Pharmaceuticals’ earnings estimates have been revised 11.1% upward for 2018 and 3.9% for 2019 over the past 60 days. The stock has surged 30.3% so far this year.

Genomic Health’s current-year earnings estimates have been moved 4.4% north over the past 60 days. The stock has soared 54.9% so far this year.

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