New haemophilia drug Elocta approved in Europe

Elocta, a new drug co-marketed by Sobi and Biogen, has been approved in the European Union.

The injectable drug has been hailed as the first meaningful advance in treating haemophilia A in 20 years, and looks set to be a big earner for the partners.

Elocta – a recombinant factor VIII Fc fusion protein (rFVIIIFc) – is already launched in the US, Canada and Australia under the Eloctate trade name, and is forecast to reach peak sales of $1.5 billion thanks to patient-friendly dosing that increases the time between injections.

Biogen is a new entrant to the haemophilia market, and hopes Elocta and its recently-approved, long-acting haemophilia B therapy Alprolix (also co-developed with Sobi) will help it win market share from established players such as Novo Nordisk, Pfizer, Bayer and Baxter.

Elocta gained approval based on clinical trials which found that once-weekly or twice-weekly injections of the drug were associated with low annualised bleeding rates. Haemophilia patients typically have to receive three or four injections a week with current treatments.

Biogen says the drug has got off to a strong start in the US, with rapid uptake among specialist haemophilia and thrombosis centres (HTCs).

But new rivals are in the pipeline, including Novo Nordisk's NN7088 and Bayer's BAY94-9027, while Baxter and CSL Behring also have long-acting products in development.

"The EC's approval of Elocta is an important milestone for the global haemophilia A community, offering the potential to improve the care of haemophilia A across the EU," said Birgitte Volck, MD, PhD, senior vice president of Development and chief medical officer of Sobi. "Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A throughout Europe."

"Elocta is the first meaningful treatment advance in haemophilia A in nearly 20 years and reinforces our commitment to improving the care of people with this disease around the world," said Gilmore O'Neill, MD, senior vice president, Drug Innovation Units at Biogen. "Since the therapy's approval in the United States last year, we have seen the benefits that extended protection against bleeds can offer people with haemophilia A, and we are excited to work with Sobi to make this innovative therapy available to people in Europe."