FDA Stalls Novo Nordisk’s Hopes of New Hemophilia Treatment, Company Cuts Wegovy Supply

Novo Nordisk’s hopes for concizumab as a prophylactic treatment for hemophilia A and B were dashed on Thursday, when the FDA rejected their application for the investigational antibody. The announcement came during the company’s first-quarter earnings call, leaving many to wonder what the next steps will be.

The regulator’s Complete Response Letter included requests for more information about the drug’s manufacturing process and the company’s system for “monitoring and dosing of patients to ensure that concizumab is administered as intended,” according to Martin Lange, Novo’s executive vice president and head of development.

During Thursday’s earnings call, Lange highlighted the importance of the regulator’s requests, emphasizing the need for a comprehensive system to guarantee the effectiveness of the drug.

Concizumab is a revolutionary monoclonal antibody designed to be administered subcutaneously. By targeting the tissue factor pathway inhibitor (TFPI) protein, which is a component of coagulation, concizumab reduces TFPI activity and promotes hemostasis – the process by which the body stops bleeding. In this way, concizumab represents a major breakthrough in the treatment of bleeding disorders.

In March 2020, Novo was forced to temporarily halt three trials involving concizumab – the Phase II EXPLORER 5 study and the Phase III EXPLORER 7 and EXPLORER 8 trials – when three patients experienced non-fatal thrombotic events. Despite this setback, Novo was able to find a way forward for the drug, and the Phase III studies were eventually resumed later in the year.

In July 2022, the company made a groundbreaking announcement – its Phase III data revealed that concizumab, when taken once-daily, could reduce both spontaneous and traumatic bleeds by an astonishing 86%. This news was met with great enthusiasm from the medical community, marking a major breakthrough in the field of bleeding disorders.

Roche has been a long-time leader in the hemophilia niche, with their first FDA-approved drug, Hemlibra (emicizumab-kxwh), proving to be a major success. In 2022 alone, the bispecific antibody generated a staggering $4.3 billion in revenue, solidifying its place as a top-selling treatment for the disorder.

Novo Cuts Low-Dose Wegovy Supply in the US

Novo has made the bold decision to reduce the supply of their groundbreaking obesity drug Wegovy (semaglutide) – a move which could have a significant impact on the treatment of this chronic condition. This temporary measure is sure to be felt by those who rely on this medication to help them manage their weight.

Wegovy is a revolutionary new GLP-1 receptor agonist approved in June 2021. This once-weekly self-injection provides an effective solution for weight control in people living with obesity. Previously known under the brand name Ozempic, Wegovy was already approved for the treatment of type 2 diabetes, making it a powerful tool to fight both obesity and diabetes.

In August 2022, Novo Nordisk found itself facing an unprecedented challenge: the overwhelming demand for their revolutionary diabetes medication, Wegovy, was outpacing their supply due to production issues at one of their contract manufacturing sites.

To ensure that patients continue to receive the care they need, Novo Nordisk, the Danish drugmaker, is temporarily reducing the supply of lower Wegovy dose strengths in the U.S. Despite taking steps to scale up production, Doug Langa, the company’s executive vice president and head of North America operations, said that this will be necessary in order to guarantee uninterrupted care.

Despite any production challenges, Wegovy’s manufacturing process is “running well” and its second contract manufacturer is “up and running and contributing,” according to Novo CEO Lars Fruergaard Jørgensen. Though the wait may be longer, patients will still have access to lower doses of Wegovy.

Novo Nordisk is reducing the supply of its low-dose strength drugs, but they are not exiting the market entirely. According to Karsten Munk Knudsen, the CFO, this is simply a measure to adjust their inventory levels.

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