In proof-of-concept trial, J&J's Invokana combo helps non-diabetics shed significant weight

Invokana

NEW ORLEANS—In diabetes trials, Johnson & Johnson’s Invokana has helped some patients lose weight--sometimes more weight than they did on another diabetes treatment. Could the drug work for weight loss in patients without diabetes?

The answer was yes in a Phase II trial presented Saturday at the American Diabetes Association Scientific Sessions. The proof-of-concept study showed that combining Invokana (canagliflozin) with the older weight-loss med phentermine delivered a 7.5% loss of body weight.

The 334-patient study tested the two-med combo against phentermine alone, canagliflozin alone, and a placebo. After 26 weeks, patients using the combo had lost 7.5% of their body weight, compared with 4.1% in those taking phentermine alone, 1.9% of those only taking canagliflozin, and 0.6% of placebo patients.

Also, almost two-thirds of the patients taking both drugs reduced their body weight by at least 5%, compared with 17.5% of placebo patients.

"The findings support the potential clinical impact that canagliflozin could have on the lives of people constantly having to manage their weight," said Dr. James List, global head of cardiovascular and metabolism at J&J’s Janssen unit. "We are committed to pursuing transformational therapies and hope to grow our understanding of how canagliflozin can be used to help more patients in the future.”

If confirmed in larger trials, the findings could have a financial impact, too. Obesity is epidemic in the U.S., so there’s no shortage of patients needing help to lose weight, and plenty of medical reasons to do so, considering its links to all sorts of serious diseases.

A relatively new generation of weight-loss drugs, however, has had little success since the first made its debut several years ago. Arena Pharmaceuticals’ Belviq, Vivus’ Qsymia, and Orexigen’s Contrave have all struggled to gain traction, and have fallen far short of initial sales expectations. These launches were all far from perfect, and they faced an uphill climb with doctors who often shy away from weight-loss drugs and payers who often refuse to cover them. But even after Arena marketing partner Eisai put hundreds of reps on Belviq, and signed more payers on to the idea, the drug failed to catch on--to the point where Eisai slashed the size of its Belviq sales force.

J&J’s fellow diabetes drugmaker Novo Nordisk is now in the mix with Saxenda, a formulation of its diabetes blockbuster Victoza that’s approved for obesity. That drug has been slow to build as well, but Novo sees enough promise in the obesity field that it has set up an obesity-focused R&D center in Seattle.

Of course, Janssen would have to take an Invokana combo into Phase III--and succeed--in order to apply for FDA approval, and then a launch would come some time after that. But with obesity a continuing problem, there’s little chance that the market would shrink before then.

But Invokana might be hampered by new cautionary language on its official FDA label. Last fall, the agency added information about potential bone density changes and fracture risks. Then again, Invokana might have a perceived CV benefit on its side. A rival SGLT2 med, Eli Lilly and Boeringer Ingelheim's Jardiance, recently showed it could stave off CV events, and that good news might be spilling over onto the rest of that drug class.

In the newly presented study data, the canagliflozin and phentermine combo delivered a statistically significant reduction in systolic blood pressure, Janssen said in a release. And the two-drug combination was “well tolerated” with no new or unexpected safety signals.

- see the J&J release

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