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JOHNSON & JOHNSON

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Johnson & Johnson : J&J Unit Gets FDA Priority Review of Invokana in Chronic Kidney Disease

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05/22/2019 | 09:37am EDT

By Colin Kellaher

Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit on Wednesday said the U.S. Food and Drug Administration granted priority review to its supplemental new-drug application for the diabetes drug Invokana in patients with chronic kidney disease.

The drug maker is seeking approval for Invokana to reduce the risk of end-stage kidney disease, the doubling of serum creatinine, and renal or cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.

Janssen said Invokana, if approved for the new indication, would be the first and only diabetes medicine to treat chronic kidney disease in patients with type 2 diabetes.

Write to Colin Kellaher at colin.kellaher@wsj.com

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Financials ($)
Sales 2019 81 223 M
EBIT 2019 25 632 M
Net income 2019 19 737 M
Debt 2019 8 612 M
Yield 2019 2,62%
P/E ratio 2019 20,12
P/E ratio 2020 18,29
EV / Sales 2019 4,78x
EV / Sales 2020 4,39x
Capitalization 380 B
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Number of Analysts 19
Average target price 149 $
Spread / Average Target 4,0%
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Managers
NameTitle
Alex Gorsky Chairman & Chief Executive Officer
Joseph J. Wolk Chief Financial Officer & Executive Vice President
Charles O. Prince Independent Director
William David Perez Independent Director
Anne M. Mulcahy Lead Independent Director
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