Biogen Idec’s long-acting haemophilia A therapy Elocta has been accepted for review by the European Medicines Agency (EMA), setting up a possible approval in 2015.
Elocta – a recombinant factor VIII Fc fusion protein (rFVIIIFc) – is already on the market in the US, Canada and Australia under the Eloctate trade name, and is predicted to become a big seller for Biogen Idec with sales of $1.5bn or more at peak thanks to its patient-friendly dosing that increase the time between injections.
Haemophilia is a new area for Biogen Idec and the company is hoping the profile of Elocta and its recently-approved, long-acting haemophilia B therapy Alprolix will help it compete in the marketplace against well-established players such as Novo Nordisk, Bayer, Baxter and Pfizer.
Eloctate was approved on the back of clinical trial results which found that once-weekly or twice-weekly injections of the drug was associated with low annualised bleeding rates. Haemophilia patients typically have to receive three or four injections a week with current therapies.
Douglas Williams, Biogen Idec’s executive vice president of R&D, commented: “The validation of Elocta’s application by the EMA is an important step toward bringing this innovative treatment to people with haemophilia A in Europe.”
In the US, Eloctate has got off to a strong start in the market, according to Biogen Idec chief executive George Scangos, who said recently it had already been prescribed at around half of all haemophilia and thrombosis centres (HTCs) in the US despite only being on the market a short time.
“We continue to believe that reduced infusion frequency is the largest unmet need for the haemophilia community,” he said. Eloctate brought in $22m in sales in the third quarter of 2014, while Alprolix – which was launched onto the market a little earlier – contributed $25m. The two new drugs have been launched with pricing on a par with their older rivals.
Other long-acting treatments in the pipeline for haemophilia A include Novo Nordisk’s NN7088 and Bayer’s BAY94-9027, while Baxter and CSL Behring also have long-acting products in trials.
Both Eloctate and Alprolix were developed in partnership with Swedish Orphan Biovitrum (Sobi), and the two companies are also working on follow-up therapies that could extend the time between injections even further, said Scangos.