EMA review for Biogen Idec’s haemophilia A therapy
pharmafile | November 4, 2014 | News story | Sales and Marketing | Biogen, elocta, eloctate, haemophilia a, idec, sobi
The EMA is set to review Biogen Idec and Sobi’s haemophilia A therapy Elocta after validating the drug’s marketing authorisation submission.
Elocta (rFVIIIFc) which is already approved in Canada, Australia and the US – where it is known as Eloctate – is a recombinant therapy that fuses factor VIII to a protein commonly found in the body, and the companies say this allows the treatment to use a naturally occurring pathway to prolong the time it stays in the body.
This helps protect against bleeding episodes and potentially allow patients to go for longer without an injection – a significant challenge for haemophilia sufferers.
Douglas Williams, executive vice president of R&D at Biogen Idec, says: “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.”
Birgitte Volck, senior vice president of development and chief medical officer of Sobi, adds: “Sobi and Biogen Idec are committed to addressing significant medical needs in the global haemophilia community. We’re working collaboratively to deliver innovative medicines that have the potential to change the way haemophilia A is treated.”
The drug is being evaluated for use in both children and adults, both of which were studied under the Phase III A-LONG trials, the results from which are included in the application. The studies only looked at male participants, however.
Biogen is leading its development and has the manufacturing and commercialisation rights in all territories except Europe, North Africa, Russia and most Middle Eastern markets. In these territories, Sobi has an opt-in right to take over final development and commercialisation.
Haemophilia A is a rare, chronic, genetic disorder which impairs the blood’s ability to clot due to missing or reduced levels of the ‘factor VIII’ protein. People with haemophilia A experience bleeding episodes that may cause pain, irreversible joint damage, and life-threatening haemorrhages.
The 2012 World Federation of Hemophilia global survey estimated that around 142,000 people worldwide live with haemophilia A.
Biogen will be holding out for EU approval after sales of its big-selling multiple sclerosis drug Tecfidera (dimethyl fumarate) recently fell short of estimates at the same time the company confirmed a patient taking the drug had developed a serious brain infection.
The patient, who had been taking the drug for four and a half years, is the first case of progressive multifocal leukoencephalopathy (PML) in a Tecfidera user. Although Tecfidera has a clean safety record, PML is a common concern of long-term MS drug usage and Biogen says the patient displayed other risk factors.
George Underwood
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