Novo Nordisk picked up European approval for a combination of a long-acting insulin and its own Victoza, pioneering a once-a-day approach to Type 2 diabetes that could bring in blockbuster sales.
Analysts have been waiting--and waiting--for drugmakers to realize the growth they've predicted for the obesity market. And with a couple of pharma companies preparing to pony up R&D and marketing resources for their obesity products, it could finally be on the way.
In the midst of its first major foray into treating obesity, Novo Nordisk is liking what it sees in the space, and now the Danish giant plans to hire hundreds of researchers in a gambit to develop new treatments for the global scourge.
Novo Nordisk bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.
On Thursday, the FDA got advice from an advisory panel that it should approve Novo Nordisk's Saxenda for obesity. Its approval would add to a struggling category a player whose expertise is with doctors treating diabetes, the physicians more likely to prescribe the drugs.
Novo Nordisk convinced a group of FDA advisers that its liraglutide, already a blockbuster diabetes treatment, can effectively combat obesity, clearing the way for a second indication that could add $1 billion to its annual sales.
Yesterday, Orexigen won FDA approval for its obesity drug Contrave, but with a "black box" warning on side effects. And patients could have yet another weight-loss choice, as a panel of FDA advisers meet today to weigh Novo Nordisk's rival drug, Saxenda.
More than three long years after Orexigen was turned back at the FDA and forced to do a costly late-stage safety study of its weight drug Contrave, the agency has come back and given its seal of marketing approval to the drug.
Novo Nordisk may be nearing the regulatory finish line with an obesity-fighting dose of liraglutide, up for debate by the FDA's advisers this week.
Novo Nordisk is nearing the weight-loss finish line. Its obesity-fighting dose of liraglutide is up for debate by the FDA's expert advisors this week, and staff reviewers issued largely positive comments in documents filed Tuesday morning.