Bayer's Jivi approved in Europe for previously treated haemophilia A

Bayer has revealed that its recombinant Factor VIII (rFVIII) replacement therapy Jivi, also known as BAY94-9027, has received approval from the European Commission for the treatment and prophylaxis of bleeding in previously treated haemophilia A patients aged 12 years or older.

As a prophylactic, Bayer recommends that Jivi be used every five days, but notes that it can also we used weekly or twice-weekly.

The EC based its decision on data drawn from the PROTECT VIII trial where 74% of patients receiving Jivi once weekly and 100% of those receiving it every five days achieved "good bleed protection", while those who stayed on the latter regimen saw a median annualised bleed rate of 0.96, with half of them experiencing no bleeds.

"Infusion frequency is a major challenge for people with haemophilia A and we believe with Jivi we can address those needs without compromising good bleed protection," commented Dr Elena Santagostino, Director of the Hemophilia Unit at the Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre of the Cà Granda Foundation, Maggiore Hospital Policlinico of Milan. "With the opportunity to offer a treatment with sustained levels of FVIII for a longer period in the blood and thus provide good bleed protection, patients and family members can feel confident that they or their loved one is well protected from bleeds and can spend more time enjoying a wider range of activities together."

The approval follows a matching ruling in the US and Japan earlier this year.

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