Ozempic and Wegovy factory in North Carolina FAILS FDA inspection – sending drug manufacturer’s shares plummeting

An Ozempic and Wegovy factory in North Carolina that helps serve millions of Americans has failed an inspection, reports suggest.

The factory was found to have ‘objectionable’ conditions by the Food and Drug Administration (FDA).

Based in Clayton, North Carolina, the drug manufacturer now has three weeks to devise an action plan to rectify the issues or risk facing further action. Novo Nordisk, which owns the factory, says manufacturing is ‘ongoing’.

The Danish company behind the blockbuster weight-loss drug Ozempic has been rapidly expanding its manufacturing capacity to meet soaring demand — with five million prescriptions for its weight loss medications written in the US last year alone.

Earlier this year there were major shortages of the drug allowing pharmacies to mix their own versions.

The report, from financial news agency Market Wire News citing sources, said the factory was issued with a Form 483.

This is given when inspectors deem a facility not to be up to scratch. The reason for the form being given was not revealed, but it could include unclean or damaged equipment, failure to properly store medications or insufficient paperwork.

The FDA inspectors are thought to have visited as part of a routine inspection, which the agency does to ensure factories are sticking to their standards.

When the report was revealed, the company’s share price dropped three percent — although it has now rallied to $187.63 per share. 

The Novo Nordisk site in Clayton includes a plant responsible for manufacturing semaglutide, the active ingredient in Wegovy and Ozempic.

This plant was opened in 2021 and was the first site outside of Denmark that the company built to manufacture the drug. It is about 400,000-square-feet, or the size of seven soccer fields.

There is also a second plant which is responsible for assembling and packaging medications including Ozempic and Wegovy.

These factories are thought to be behind a large portion of the US supply of Ozempic and Wegovy, with disruption at the facility risking shortages of the drugs.

The FDA currently still lists four semaglutide injections — three for Wegovy and one for Ozempic — as having limited availability.

Two Ozempic shots are also listed as ‘currently available’.

Novo Nordisk, based in Denmark, has refused to comment on the reports, but said the factory was still ‘running and producing for the market’.

The FDA did not respond to requests for comment, but does not typically comment on individual companies.

Novo Nordisk also has a third factory in the area 40 miles away in Durham, which makes a tablet version of semaglutide — sold under the brand name Rybelsus.

Ozempic has taken America by storm for its promise to help someone shed the pounds with just one injection per week.

Approved for treating type 2 diabetes, the medication is also being prescribed off-label to other people to help them lose weight.

It works by suppressing feelings of hunger and slowing the digestive system, leading someone to eat less because they feel full for longer. This prompts weight loss.

It comes after an analysis revealed Ozempic, Wegovy and Rybelsus are up to ten times more expensive in the US than in other wealthy countries. 

An analysis of prices in 10 countries by the Kaiser Family Foundation (KFF) found a one-month supply of Ozempic — which is approved to treat diabetes but is often prescribed off-label for weight loss — has a list price of $936 in the US.

A list price is the cost the manufacturer of the drug publicly prices it when selling to wholesalers, who purchase drugs from manufacturers to sell to pharmacies, hospitals and clinics.

 While the list price does not necessarily reflect what consumers will pay, patients often need to pay more to offset the price the manufacturers set.

Source: | This article originally belongs to Dailymail.co.uk