11:04 AM EDT, 06/25/2024 (MT Newswires) -- Novo Nordisk ( NVO ) secured Chinese regulatory approval for its weight loss drug for cardiovascular risk reduction, while the Danish drugmaker plans to invest $4.1 billion to expand its manufacturing capacity in the US.
China's National Medical Products Administration "recently" cleared the Wegovy injectable prescription medicine, the company said Tuesday in a statement translated from Chinese. The drug is used to reduce the risk of major cardiovascular events, such as heart attack and stroke in adults with overweight or obesity.
In an emailed response to MT Newswires, the company said Wegovy will initially be available to patients with a body mass index of 30 kg/m2, or 27 kg/m2 for those with at least one weight-related comorbidity. The firm didn't disclose pricing details and hasn't yet announced launch plans.
In March, the US Food and Drug Administration approved Wegovy after trial data showed it "significantly" reduced the risk of major adverse cardiovascular events by 20% compared to a placebo, according to Novo Nordisk ( NVO ). The company also said at the time that it filed for a label expansion in the European Union, with a decision expected this year.
Wegovy logged overall sales of 9.38 billion kroner ($1.35 billion) in the first quarter, representing an annual jump of 106%, the drugmaker reported last month. In the US, sales jumped by 86% as the firm said it reduced supply of lower Wegovy dose strengths since May last year to "safeguard continuity of care," as demand for the product exceeds supply.
In a separate statement late Monday, Novo Nordisk ( NVO ) said it will invest $4.1 billion to develop a second fill and finishing manufacturing facility in North Carolina, as part of plans to boost the production of its treatments for obesity and serious chronic diseases. The company has already started clearing and foundational work for the plant and anticipates construction to be gradually finalized between 2027 and 2029.
"This is yet another real signal of our efforts to scale up our production to meet the growing global need for our life-changing medicines and the patients of tomorrow," Chief Executive Lars Jorgensen said.
The expansion is expected to add 1.4 million square feet of production space and create 1,000 jobs, according to the company. Novo Nordisk ( NVO ) aims to spend $6.8 billion in 2024 to increase production, up from the $3.9 billion it spent last year.
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