With FDA panel backing, Novo Nordisk prepares for semaglutide's potential launch

Mads Krogsgaard Thomsen, Novo Nordisk's head of R&D, said the company's forthcoming semaglutide would be priced in line with other GLP-1 drugs if it wins FDA approval later this year.

Novo Nordisk is one step closer to approval for semaglutide, the weekly diabetes drug it sees as a best-in-class follow-up to its blockbuster daily injection, Victoza. In a 16-0 vote, an FDA panel of experts backed the medication for approval, clearing the way for an agency decision by the end of the year.

If approved, semaglutide has the potential to be one of Novo’s growth engines as competition heats up in the GLP-1 class. With some head-to-head trial data on its side, semaglutide would be a strong contender against Eli Lilly’s Trulicity, which has been gaining market share from Victoza since its launch last year.

Novo also hopes semaglutide would help expand the drug class itself, which right now only registers a single-digit share among the entire range of diabetes treatments, R&D chief Mads Krosgaard Thomsen said Thursday morning during a call with analysts.

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Though semaglutide’s initial launch will likely be fueled by switches from other GLP-1 drugs—including from Victoza itself—the aim for GLP-1 companies will be to attract patients who haven’t used a GLP-1 drug before. “That is exactly what provides the market expansion, and that is what an agent that is easy to use with the efficacy level of semaglutide ... is able to do,” Thomsen said, “so we are not targeting switches, we are targeting the market growth with this agent.”

And as CMO Todd Hobbs told FiercePharma in an interview ahead of the panel vote, semaglutide’s trial data supports a case against other drug classes.

“The efficacy of semaglutide across eight trials was consistently, significantly better than comparators including a DPP-4 drug, including Bydureon, including [insulin] glargine,” Novo Nordisk CMO Todd Hobbs said in an interview ahead of the vote, citing the drug’s trial beats against Merck’s Januvia, AstraZeneca’s fellow GLP-1 drug Bydureon and Sanofi’s Lantus, now available as a biosimilar.

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Novo expects to price semaglutide in line with other GLP-1 drugs, which are already on the high end of the pricing spectrum in diabetes, Thomsen said. Early this year, the market intelligence firm EvaluatePharma pegged the drug as one of 2017’s top launches, with a 2022 sales forecast of $2.2 billion.

For the FDA panel, semaglutide’s ability to lower blood glucose and help patients lose weight outweighed questions raised about potential eye-related side effects, which had cropped up in one of eight trials testing semaglutide against type 2 diabetes. Sixteen panelists voted for approval, and one abstained.

Next up are label discussions with the FDA, which are likely to focus on two things, Thomsen said: One, flagging the risk of worsening diabetic retinopathy, whether in the warnings section or among the adverse events, and perhaps worded similarly to the statements on existing insulin labels.

Two, whether Novo can include data from its cardiovascular outcomes study, Sustain-6, which not only showed that semaglutide was safe—as the panelists discussed Wednesday—but suggested CV benefits as well.

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And meanwhile, the company will be working on reimbursement deals with payers, which have already set up their 2018 formularies, but still could choose to cover semaglutide next year. 

The big discussion point going into the advisory committee meeting—data in one trial, Sustain-6, showing more patients taking semaglutide suffered complications of diabetic retinopathy—triggered debate among the panel experts.

One issue was that Novo didn’t screen trial patients for retinopathy ahead of enrollment in Sustain-6 and the ophthalmologic complications cropped up in participants with a severe form of the condition. About 30% of the trial participants had some background risk of eye problems, Hobbs said, and there were more patients in the semaglutide arm that had a history of proliferative retinopathy. Previous semaglutide trials hadn’t flagged retinopathy and its complications as safety risks. 

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“We certainly didn’t anticipate anything around retinopathy,” Hobbs said. “In trials moving forward we want to get retinal photography to really understand the background risk.”

That sort of monitoring isn’t commonly done in diabetes trials, he said, but “there are all kinds of tools to measure retinopathy progression in a very specialized way that you could use if you were tracking this.”

Keeping count of the eye problems—among several secondary endpoints in the trial—was done by spontaneous reporting, rather than with diagnostic tools such as imaging, which in itself raises questions about the validity of the numbers.

Given that the Sustain-6 outcomes trial was relatively brief, with fewer patients than a trial designed to prove CV benefits, Novo did not ask the FDA for a CV risk-reduction claim for semaglutide. The company does plan a more extensive follow-up study to assess those benefits, just as it did with Victoza, which now has an FDA approval as a CV risk-reduction tool.