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EMA clears Novo Nordisk’s long-acting haemophilia A drug

Entering newly competitive market

Novo Nordisk

Novo Nordisk has gained EU approval for its new haemophilia A treatment Esperoct, a long-acting factor VIII replacement therapy that is part of the company’s efforts to prop up its blood disorder franchise.

Esperoct (turoctocog alfa pegol) is a follow-up to Novo Nordisk’s NovoEight product and allows patients to inject themselves once every four days, rather than every other day or three times weekly.

The EMA has approved the new product for prophylaxis and on-demand treatment of bleeding in adolescents (12 and over) and adults with haemophilia A, with the green light coming a few weeks after Esperoct was cleared by the FDA, and Novo Nordisk says it will start launching it in the EU in the second half of 2019.

The company is prevented from launching the new drug in the US until next year however, as it is tied up by ‘third-party intellectual property agreements’.


Mads Krogsgaard Thomsen

“We are confident that Esperoct will provide people with haemophilia A a less burdensome and simple, fixed dosing regimen for prophylaxis and treatment of bleeding episodes, resulting in improved quality of life,” said the Danish drugmaker’s chief scientific Mads Krogsgaard Thomsen.

Consensus analyst forecasts suggest Esperoct’s sales will peak at around $284m in 2025, which will be an advance on NovoEight’s sales of around $205m last year.

That is a positive for Novo Nordisk’s overall haemophilia franchise which is being hit by declining sales of factor VII replacement product NovoSeven, but there’s little doubt that the company will have to work hard to build a share of a crowded market.

Takeda’s Shire unit already has a long-acting factor VIII product on the market in Adynovate, as does Sanofi with Eloctate from its recent Bioverativ acquisition, Bayer with Kovaltry, and CSL Behring with Afstyla, so Esperoct has direct competition right off the bat.

Meanwhile, Roche’s fast-growing antibody Hemlibra (eculizumab) is disrupting the market and putting pressure on all the factor VIII replacement products en route to what some analysts reckon could be peak sales of $4bn to $5bn.

Novo Nordisk is also going down the antibody route with concizumab, which will try to take on Hemlibra if phase 3 trials due to start later this year are positive, but the entire therapeutic category could be turned on its head if one-off gene therapies from the likes of BioMarin and Spark are approved.

The EU and US approvals of Esperoct are based on data from a trial which included 270 previously treated people with severe haemophilia A and more than five years of clinical exposure to factor VIII replacement therapy.

In the trial, Esperoct provided effective prophylaxis and maintained a low median annual bleed rate of 1.18. It was also found to be efficacious in treatment and control of bleeding episodes, and was well tolerated.

Article by
Phil Taylor

24th June 2019

From: Marketing



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