J&J's Invokana Approved in the US - Analyst Blog

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Johnson & Johnson 's ( JNJ ) Janssen Pharmaceuticals, Inc. recently gained US Food and Drug Administration (FDA) approval for its oral, once-daily, type II diabetes treatment, Invokana.

Invokana's approval was largely expected as the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had voted 10 - 5 in favor of its approval earlier this year.

We note that the FDA has asked Johnson & Johnson to conduct five post-marketing studies with Invokana. These include a cardiovascular outcomes trial; an enhanced pharmacovigilance program for monitoring malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA). The pediatric studies will include a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

Invokana's approval is a major positive for Johnson & Johnson. Invokana is the first in a new class of drugs called sodium glucose co-transporter 2 (SGLT2) inhibitors to gain approval in the US. Study results have shown that Invokana improves glycemic control while reducing body weight and systolic blood pressure.

Other SGLT2 inhibitors include Eli Lilly's ( LLY ) empagliflozin (new drug application filed in the US and under review in the EU) and Bristol-Myers Squibb ( BMY ) and AstraZeneca's ( AZN ) Forxiga (approved in the EU).

With Invokana being the first SLGT2 inhibitor to launch in the US market, we expect the product to capture a major share of the market.

Johnson & Johnson currently carries a Zacks Rank #4 (Sell). Currently, Eli Lilly looks well-positioned with a Zacks Rank #2 (Buy).



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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: AZN , BMY , JNJ , LLY , PREA

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