Novo Nordisk ($NVO) is hustling to get work done so that it can resubmit its blockbuster hopeful Tresiba to the FDA next year with an eye on getting into the market by 2016, three years after the FDA squelched its plans with its initial denial. In the meantime, Novo is finding new ways to combo Tresiba up and sell it in Europe where it is approved.
The Danish drugmaker has nabbed an EU nod for Xultophy, a once-a-day injection of a fixed-dose combo of Tresiba and its blockbuster Victoza. The EU regulators approved Xultophy for the treatment of adults with type 2 diabetes in combination with oral glucose-lowering drugs when those alone or in combination haven't kept patients' blood sugars adequately in check, PharmaTimes reports.
Analysts have forecast Xultophy could have peak sales at around $1 billion a year, but that would be dependent on getting U.S. approval and that won't happen unless the FDA grants approval to Tresiba.
Novo's highly anticipated Tresiba was expected to be a head-on competitor with industry giant Lantus. It had good data that showed it could outperform the Sanofi ($SNY) drug at nighttime control of blood sugars in diabetics but that was not enough to overcome FDA worries over cardiac risks. The agency sent it back for more testing, a heavy blow for Novo which had expected Tresiba to lead its growth.
The drugmaker has said it expects to report critical clinical trial data on the long-acting insulin treatment in mid-2015--6 months sooner than expected. That should put it in line for an approval in 2016.
While it works toward that, other players are trotting their own new diabetes treatments. Eli Lilly ($LLY) Thursday garnered FDA approval for its new drug Trulicity, a once-weekly dulaglutide, which spurs natural insulin secretion and pushes excess sugar out of the body. Trulicity diabetes med is expected to surpass the $1 billion blockbuster benchmark and will compete directly against such drugs as AstraZeneca's ($AZN) Byetta, Merck's ($MRK) Januvia and metformin in controlling blood sugar in Type 2 diabetes.
But Novo has taken note of the development of the Lilly drug. Novo Nordisk CEO Lars Sorensen told FierceBiotech recently, "I think it's a good product," but then said he believed it is "slightly inferior to Victoza."
- read the PharmaTimes story
- here's the FDA Trulicity announcement