UPDATED: FDA hands Eli Lilly a big win, OKs dulaglutide for diabetes

Lilly Diabetes President Enrique Conterno

An embattled Eli Lilly ($LLY) won a major battle today, gaining the FDA's approval to market dulaglutide for Type 2 diabetes. It will be sold as Trulicity.

With Novo Nordisk ($NVO) already digging in to defend its position around Victoza, the once-weekly treatment has been widely billed as a likely blockbuster. The Phase III program has long represented Eli Lilly's best shot at opening a major new market, though many analysts are still wondering just how much revenue can be gained in this already crowded field.

The market, though, is huge and growing as a tidal wave of diabetes rises around the world.

"Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of type 2 diabetes," said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

Lilly tailored its 9-part Phase III program to pit dulaglutide against its most likely competitors, and the drug is yet to disappoint. Lilly's once-weekly treatment has thus far bested AstraZeneca's ($AZN) Byetta, Merck's ($MRK) Januvia and metformin in controlling blood sugar in Type 2 diabetes.

In its latest results, presented at the American Diabetes Association conference, dulaglutide proved itself noninferior to Novo Nordisk's blockbuster Victoza--the $2 billion-a-year standard-bearer among GLP-1 therapies. That's the first time a once-weekly GLP-1 agent has ever equaled a daily one in a Phase III trial, Lilly said--including GlaxoSmithKline's recently approved Tanzeum. And it will be at the heart of Lilly's campaign to sell this treatment as a more convenient alternative to Victoza.

But the approval came with some important strings.

The drug will come with a boxed warning raising links between the treatment and tumors found in the thyroid glands in rodents. And Eli Lilly will be on the hook for a range of post-marketing studies, including:

  • A study to evaluate dosing, efficacy, and safety in pediatric patients. 
  • A study on its effects regarding sexual maturation, reproduction, and CNS development and function in immature rats.
  • A trial comparing Trulicity with insulin glargine on glycemic control in patients with type 2 diabetes and moderate or severe renal impairment,
  • And a cardiovascular outcomes trial to evaluate the cardiovascular risk of Trulicity in patients with high baseline risk of cardiovascular disease.

Regardless of the conditions, though, the approval marks a major step forward for a company which has gone through a long dry spell in the clinic. This year will be its toughest, with generic competition clawing away a big chunk of its annual revenue from its top drug franchises. Other drugs either approved or up for a near-term decision at Lilly don't have nearly the market potential that dulaglutide has represented.

"As part of our commitment to provide a broad range of products and practical solutions to help make life better for people with diabetes, we're excited to add this newest treatment option to our comprehensive portfolio," Lilly Diabetes President Enrique Conterno said in a statement.

Now the focus will turn to the marketing department, to see if Lilly can deliver on high expectations or whether the market will prove harder to crack, as Novo CEO Lars Sorensen predicts.

"I think it's a good product," the CEO recently told FierceBiotech. The rival treatment is "slightly inferior to Victoza" on blood sugar and weight, he added. But he's clearly bracing for a competitive showdown, even as other rivals barely warrant a mention. 

Peak sales projections for dulaglutide are all over the map. Cowen has pegged the potential at $700 million, with Bernstein's Tim Anderson now projecting $1.3 billion in 2020. That's not enough to make up for the patent losses, but it would go a long way to providing some credibility for an R&D group that is drawing an increasing amount of critical scrutiny. 

- read the release

Special Report What's next in diabetes drugs? The pulse of R&D at ADA14

Damian Garde contributed to this report.

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