Johnson & Johnson
) 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
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
Other SGLT2 inhibitors include
) empagliflozin (new drug application filed in the US and under
review in the EU) and
) 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
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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