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Bayer roll-out of haemophilia drug Jivi gathers pace

Japan’s MHLW is next to approve the drug

Bayer

Bayer has added another big market for its new haemophilia A product Jivi, adding approval in Japan to a green light in the US a few weeks ago.

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Jivi (damoctocog alfa pegol/BAY94-9027) – a long-acting form of recombinant Factor VIII – to prevent bleeds in adults and adolescents 12 years of age or older with haemophilia A. As in the US, the drug is approved in Japan for on-demand treatment and bleeding management during surgeries. It’s also been filed for approval in Europe and is under regulatory review.

Jivi is another option in an increasingly crowded market for haemophilia A therapies, and Bayer is hoping that the new products dosing schedule will prove popular with patients and physicians. It is given twice a week at the outset and can be reduce to once every five days – or even less – if the patient maintains good bleeding control.

“The approval of Jivi allows certain patients with haemophilia A to preserve coagulation factor levels to prevent bleeding with just one infusion per week,” says Teruhisa Fujii, director of the blood transfusion division at the Hiroshima University Hospital. “This represents an important improvement, allowing patients more flexibility in their lifestyles.”

Despite efforts to transition patients from daily injections of Factor VIII to long-acting variants which can be given every few days, such as Bayer’s own Kovaltry, Shire’s Adynovate and Eloctate, and CSL Behring’s Afstyla, uptake hasn’t been as quick as many had hoped, so Jivi is entering a challenging market.

Bayer’s existing Factor VIII treatments – short-acting Kogenate and Kovaltry – had combined sales of €967m last year.

Meanwhile, the imminent regulatory verdict in the US for Roche’s Hemlibra (emicizumab) in haemophilia A patients without inhibitors to factor VIII, which could dramatically broaden the number of patients eligible for treatment with the once-monthly injection, could hit sales of Factor VIII products across the board.

In the longer-term, all these drug therapies could be superseded by one-shot gene therapies for the disorder that are showing promise in early-stage testing from the likes of BioMarin and Spark Therapeutics.

Article by
Phil Taylor

21st September 2018

From: Regulatory

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