Novo Nordisk’s Hemophilia Hopeful Hits FDA Roadblock, Company Cuts Wegovy Supply
Novo Nordisk flag flies in the wind/Courtesy joreks, Shutterstock
The FDA has rejected Novo Nordisk’s application for its investigational antibody concizumab, proposed for the prophylactic treatment of hemophilia A and B, the company announced on Thursday during its first-quarter earnings call.
In its Complete Response Letter, the regulator asked for more information regarding the drug’s manufacturing process and the company’s system for “monitoring and dosing of patients to ensure that concizumab is administered as intended,” Martin Lange, Novo’s executive vice president and head of development, said during Thursday’s earnings call.
Designed to be administered subcutaneously, concizumab is a monoclonal antibody targeting the tissue factor pathway inhibitor (TFPI) protein, a component of coagulation. By turning down the activity of TFPI, concizumab promotes hemostasis, the process by which the body stops bleeding.
In March 2020, Novo had to pause three concizumab trials – the Phase II EXPLORER 5 study and the Phase III EXPLORER 7 and EXPLORER 8 trials – after three patients developed non-fatal thrombotic events. Later the same year, the company resumed the Phase III studies of concizumab after it had worked with authorities to find “a new path forward” for the drug, Novo said at the time.
In July 2022, the company posted positive Phase III data showing that once-daily treatment with concizumab could reduce spontaneous and traumatic bleeds by 86%.
The hemophilia niche is so far dominated by Roche, whose Hemlibra (emicizumab-kxwh) was first approved by the FDA in 2017. In 2022, the bispecific antibody raked in nearly $4.3 billion in revenue.
Novo Cuts Low-Dose Wegovy Supply in the US
Novo also announced it was temporarily reducing the supply of its obesity drug Wegovy (semaglutide).
Wegovy is a GLP-1 receptor agonist approved in June 2021 as a once-weekly self-injection for weight control in people living with obesity. This drug had previously been approved under the brand name Ozempic, which is indicated for the treatment of type 2 diabetes.
In August 2022, one of the company’s contract manufacturing sites encountered production problems, which led to a growing gap between the overwhelming demand for Wegovy and Novo’s supply.
The Danish drugmaker has since taken steps to scale its production capacity, but “to safeguard continuity of care, the supply of the lower Wegovy dose strengths in the U.S. will be reduced temporarily,” Doug Langa, Novo’s executive vice president and head of North America operations, said Thursday.
Still, the manufacturing of Wegovy is “running well” and the company’s second contract manufacturer is “up and running and contributing,” Novo CEO Lars Fruergaard Jørgensen said during the call. Patients will still have access to lower doses of Wegovy, though it might require a longer wait.
“We’re not out of the market with the low-dose strengths. We’re just reducing supply,” Novo CFO Karsten Munk Knudsen said.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at firstname.lastname@example.org or email@example.com.