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Roche gets EU nod for much-expanded Hemlibra label

Drug is now suitable for all age groups with multiple dosing options


The EMA has approved Roche’s Hemlibra for use in the majority of patients with haemophilia A, extending its use beyond the minority who have developed resistance to factor VIII drugs.

The EU medicines regulator has approved Hemlibra (emicizumab) to prevent or reduce the frequency of bleeding episodes in children and adults with haemophilia A without inhibitors – antibodies that bind to factor VIII replacement drugs and stop them working effectively.

Roche says that the expanded label means Hemlibra is now suitbale for “all age groups, and can also now be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A”.

The EMA approval means Hemlibra is now approved for haemophilia A patients with and without inhibitors on both sides of the Atlantic, allowing it to challenge the full range of current treatments on the market.

The product’s patient-friendly dosing schedule is already finding favour with patients who are used to having to inject factor VIII replacement drugs multiple times per week, and driving rapid uptake.

Sales reached around $2.4bn in 2018, its first full-year on the market, even though of the bulk of the year it was only indicated for the smaller group of patients with inhibitors, and was fuelled by competitive pricing compared to factor VIII replacement.

Turnover has been almost doubling quarter-on-quarter, with broad uptake across both paediatric and adult patients, according to Roche.

The head of Roche pharmaceuticals division, Bill Anderson, said recently the rate of patients switching to Hemlibra had exceeded the company’s expectations, as it had expected some resistance among those at the severe end of the disease spectrum who have grown accustomed to receiving factor VIII infusions over decades.

“I think it's going to take probably another couple of quarters before we think we've figured out what the real trend line is,” he said. Some analysts have suggested the drug could eventually turn into a $5bn-plus product.

Hemlibra is a bispecific antibody that binds to factor IXa and factor X, mimicking the role factor VIII plays in the blood. It achieved a significant and clinically meaningful reduction in the number of treated bleeds in the phase 3 HAVEN 3 and HAVEN 4 studies, cutting bleeds by 68% compared to prior factor VIII prophylaxis.

Roche’s chief medical officer Sandra Horning said the EMA approval is “a landmark moment as Hemlibra is the first new class of treatment for people with severe haemophilia A without inhibitors in nearly 20 years”.

“We will continue to work with EU member states, to bring this important treatment to those in need as quickly as possible,” she added.

Article by
Phil Taylor

14th March 2019

From: Regulatory



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