Please ensure Javascript is enabled for purposes of website accessibility

The Next-Generation Therapy to Treat Type 2 Diabetes Has Arrived

By Sean Williams - Apr 1, 2013 at 6:00PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

This newly approved all-oral diabetes therapy offers the promise of greater efficacy and fewer serious side effects and it could even help you shed a few pounds.

OK, so it's not nearly as dramatic as Captain Kirk beaming up from a planet's surface to The Enterprise, but the approval of Johnson & Johnson's (JNJ 0.19%) Invokana is a revolutionary breakthrough for those who suffer with Type 2 diabetes, or T2D.

A new pathway to glycemic balance
On Good Friday no less, the Food and Drug Administration approved J&J's Invokana, ushering in a completely new method by which T2D can be treated. You see, Invokana is an SGLT2 inhibitor and works by a completely different pathway than oral DPP-4 inhibitors, which are the current hot thing in T2D care. DPP-4 inhibitors like Merck's (MRK 0.46%) Januvia work by reducing glucagon and blood glucose levels through hormones in the pancreas and liver. However, they've also been linked with potentially serious side effects like pancreatitis, kidney problems, and severe allergic reactions. But that hasn't stopped Januvia from racking up annual sales in excess of $4 billion.

J&J's Invokana -- which was developed by its subsidiary Janssen Pharmaceuticals – is an oral drug that works in the kidneys by blocking the reabsorption of glucose and allowing the body to rid excess glucose through the urine. The end result is a more normalized glycemic balance, with the added benefit of weight loss even though Invokana isn't indicated for weight loss. This is a welcome change since the majority of previous T2D treatments actually induce weight gain in patients.

Improvement seen one step at a time
The approval of Invokana itself wasn't a guarantee even though the clinical trials suggested it would breeze through an FDA approval. Invokana effectively reduced A1C levels, lowered systolic blood pressure, and provided modest weight loss, all at the expense of the placebo, which, in this case, was Merck's Januvia.

However, a gray cloud overhung its PDUFA meeting in the form of a complete response letter for Forxiga, an SGLT2 inhibitor from AstraZeneca (AZN -1.02%) and Bristol-Myers Squibb (BMY -0.98%) that was denied approval in Jan. 2012. Although Forxiga has found success in Europe, where it was approved in November -- and became the first SGLT2-inhibiting drug approved in the world – it was denied a U.S. approval due to concerns about elevated breast and bladder cancer risks from taking the drug.

It's also not hard to understand why the FDA is more stringent when it comes to safety concerns in T2D treatments as GlaxoSmithKline's (GSK -0.23%) T2D drug Avandia resulted in one of the largest recalls in U.S. history. All told, GlaxoSmithKline settled in 2012 for $3 billion and it's estimated that Avandia could have resulted in 50,000 to 100,000 deaths due to increased heart attack risks associated with the drug.

Invokana, despite the approval, won't get a free pass. It was shown to cause yeast infection and urinary tract infections (which is expected given the excess sugar being secreted by a patient), but will also need to follow up with five additional longer-term safety trials. Specifically, J&J will be tracking cases of heart problems, cancer, pancreatitis, and liver problems.

A blockbuster in the making
Those concerns aside, Invokana appears to be a vast improvement in T2D patient care, providing fewer and less severe side effects with great efficacy and the added bonus of weight loss. Peak sales estimate for Invokana vary depending on whom you ask, but commonly settle around $1 billion. This figure could prove to be far too low considering that it mopped the floor with Januvia, is priced competitively with existing T2D medications, and faces a big boost when Januvia's patents begin to expire in 2017. Also, as I noted in February, the next-generation of T2D treatment following SGLT2 inhibitors, such as glucokinase activators, are still a long way from gaining approval.

At the moment, I'd say the future of T2D treatments is J&J's market to lose.

link

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Johnson & Johnson Stock Quote
Johnson & Johnson
JNJ
$177.85 (0.19%) $0.34
Merck & Co., Inc. Stock Quote
Merck & Co., Inc.
MRK
$91.59 (0.46%) $0.42
Bristol Myers Squibb Company Stock Quote
Bristol Myers Squibb Company
BMY
$76.25 (-0.98%) $0.76
GSK Stock Quote
GSK
GSK
$43.43 (-0.23%) $0.10
AstraZeneca PLC Stock Quote
AstraZeneca PLC
AZN
$65.39 (-1.02%) $0.68

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
311%
 
S&P 500 Returns
110%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 07/01/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.