Diabetes, Regulatory

Novo bets on swift FDA review for oral diabetes drug semaglutide

The world’s top diabetes drug maker Novo Nordisk is in a hurry. As part of its fourth-quarter results on Friday, the company $NVO said it was planning to use a priority voucher to hasten the FDA review process for its potential blockbuster oral GLP-1, semaglutide, a critical component of the Danish drugmaker’s long-term growth strategy.

The company has spent nearly a century leaning on its roster of injectable diabetes treatments, but as competition heats up and pricing pressure in the United States intensifies, Novo is betting on a pill to entice patients who are averse to injections or those who haven’t so far required injections to manage their insulin levels. An estimated 425 million people globally suffer from diabetes, according to the International Diabetes Federation.

The drug, like others in its class, is a GLP-1 treatment that stimulates insulin production. Last year, late-stage data showed Novo’s pill outperformed a placebo and in a head-to-head trial beat Boehringer Ingelheim and Eli Lilly’s Jardiance, an oral SGLT2-inhibitor approved back in late 2016. Novo’s once-a-week injectable version of semaglutide — called Ozempic — was launched in the United States last February and has now captured 26% of the weekly new-to-brand prescription market share, Novo said on Thursday. Arch-rival Lilly’s once-weekly blockbuster injectable GLP-1 Trulicity is currently the market leader.

The GLP-1 pill will be submitted for US review at the end of the first quarter of 2019, and Novo will submit a priority review voucher in tandem, which should speed up the FDA process to six months, versus the standard 10 months.

If approved, focus will turn to the price of Novo’s medicine, as the soaring cost of drugs in the United States triggers the ire of patients and politicians alike. Anecdotal reports of diabetics rationing or foregoing insulin have elicited widespread criticism, and in recent years lawmakers across the aisle have proposed a raft of policies to tackle the larger issue of drug pricing, which is also considered a top priority by US voters.

“We see risk apprehension grows on GLP-1 pricing, notably around 2023E Victoza generics, but also from US payers as the class balloons and when oral semaglutide is launched at a lower price point,” Jefferies analysts wrote in a note on Friday.

A Novo spokesperson declined to comment on the company’s pricing plans for oral semaglutide. The drug is expected to generate about $2.2 billion in sales in 2024, according to Evaluate Pharma estimates.

Meanwhile, Novo is also navigating a soup of Brexit uncertainty. The company is the biggest supplier of insulin to the UK, but with no clarity on Britain’s departure, the drugmaker has put together a contingency plan. The preparations includes stockpiling ahead of March 29 — the expected date of Britain’s departure from the EU — and scheduled monthly airfreight slots between April and July 2019 to ensure supply isn’t disrupted. In a statement mid-January, Novo said it would have doubled its UK stock to 16 weeks by the end of the month.


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