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Novo Nordisk submits diabetes pill for U.S. approval

FILE PHOTO: The logo of Danish multinational pharmaceutical company Novo Nordisk is pictured on the facade of a production plant in Chartres, north-central France, April 21, 2016. REUTERS/Guillaume Souvant

COPENHAGEN (Reuters) – Novo Nordisk has submitted its oral semaglutide drug, a pill it hopes will transform the diabetes market, for approval in the United States.

The once-daily pill for treatment of type 2 diabetes is an important growth prospect for the Danish drugmaker, which faces pressure on prices from competitors and U.S. lawmakers, who have been critical of rising drug prices.

The world’s biggest maker of diabetes drugs said on Wednesday it had used a so-called priority review voucher to speed up the anticipated review time of the drug to six months.

The tablet belongs to a blockbuster class of treatments known as GLP-1s that stimulate insulin production.So far, all have been via injection and a pill would make it quicker and easier for diabetics to take their medication.

“Many people don’t like to inject themselves with a needle,” Novo’s chief scientific officer Mads Krogsgaard Thomsen told Reuters. He said having to inject the drug also tended to make people feel more sick and others to consider them as more sick.

He declined to comment on the pricing of the tablet due to competitive reasons.

The semaglutide molecule is the backbone of Novo’s future growth hopes amid intensifying pricing pressure in its traditional insulin business.

“Semaglutide is a spearhead into a number of new disease areas,” Thomsen said.

Novo is already selling an injectable once-weekly version of semagalutide under the brand name Ozempic and is further testing the molecule in obesity, non-alcoholic steatohepatitis, known as fatty liver, as well as cardiovascular and chronic kidney diseases.

Reporting by Stine Jacobsen; Editing by Kirsten Donovan and Jane Merriman

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