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Roche and Chugai's Hemlibra scoops up EU approval in the prevention of severe haemophilia A without factor VIII inhibitors

Roche has announced along with its partner Chugai that Hemlibra (emicizumab) has secured approval from the European Commission as a preventative treatment for bleeding episodes in patients with severe haemophilia A without factor VIII inhibitors.

The drug is suitable for use in any age of patient and can be self-administered via subcutaneous injection every one, two or four weeks. It already held authorisation for the treatment of haemophilia A with factor VIII inhibitors

Hemlibra shows "clinically meaningful" bleed control in paediatric haemophilia A patients

In another reveal at the American Society of Hematology (ASH) Annual Meeting 2018, Roche unveiled new Phase 3 findings for Hemlibra (emicizumab) as a prophylactic in haemophilia A patients with factor VIII inhibitors younger than 12 years of age.

The data, drawn from the largest pivotal study of this patient population, showed that 76.9% of participants treated once weekly experienced zero treated bleeds over the course of the study period.

FDA expands indication of Roche's Hemlibra in haemophilia

The FDA has chosen to expand the label of Roche’s Hemlibra (emicizumab-kxwh), approving it for routine prophylaxis to prevent the frequency of bleeding episodes in all adults and children with haemophilia A without subcutaneous factor VIII inhibitors, it has emerged.

The expansion covers several dosing options - once weekly, every two weeks or every four weeks – and is based on the findings of two Phase 3 trials which demonstrated that Hemlibra led to “statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis”, meeting its primary e

Roche’s Hemlibra stakes claim to be haemophilia market leader

Hemlibra was widely expected to become the dominant therapeutic for treating haemophilia patients and its latest clinical trial results only cements its prospects in the field.

In two Phase 3 clinical trials, Hemlibra was able to demonstrate benefits to patients who did or did not receive factor VIII inhibitors.

In patients who had not received inhibitors, 96% showed a reduction in treated bleeds compared to those who received nothing. In addition to this, 55% of these patients experienced no treated bleeds.

Top Ten most popular articles on this week

As we approach the Easter weekend, we at Pharmafocus hope all of our readers have a great long weekend, if you're lucky enough to benefit from one. That also means that this week's Top Ten comes a little earlier than usual.

Five deaths linked to Roche's haemophilia drug Hemlibra

Roche has been rocked by the revelation that there have been five patient deaths linked to the use of its bispecific factor IXa- and factor X-directed antibody Hemlibra (emicizumab-kxwh), sending its shares slipping.

The Hemophilia Federation of America (HFA) announced the news after it said it had been informed of the deaths directly by Roche’s biotech subsidiary Genentech. It means that there have been four more fatalities in addition to the death reported last year.

Europe approves first therapy for haemophilia A with inhibitors in over 20 years

Roche has revealed that its bispecific factor IXa- and factor X-directed antibody Hemlibra (emicizumab) has been approved by the European Commission (EC) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors.

Roche's haemophillia A treatment gets nod but with black box warning

Roche needs its pipeline to pick up quick successes, with its big earners are looking at precipitous patent cliffs, and, as the FDA approves its haemophilia A medicine, it looks like it may be delivering.

The treatment will be known as Hemlibra and has been approved to treat patients who have developed inhibitors to factor VIII replacements therapies. The approval came earlier than expected, with a decision expected at any point up until 23 February, which should help the treatment hits its predicted peak sales of $1.6 billion by 2022.

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