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Roche, a Swiss multinational healthcare company is drunk on success right now! Well they cannot be blamed, as their hemophilia A drug candidate has now cleared the HAVEN-1 trial and has all the makings of a blockbuster drug.

Earlier in February, word got out about the death of one of the three patients suffering from thrombotic micro-angiopathy after consuming emicizumab. The patient was treated with a BPA and Roche sees the adverse events as a result of treatment with repeated high doses of on-demand BPAs to treat breakthrough bleeds.

Now however, the bispecific antibody has been able to cut the rate of bleeding by an astounding 87% in patients with inhibitors to factor VIII and has aced all the secondary endpoints, ousting even small amounts lingering concerns about side effects as the main barrier between the company and big sales. And considering its efficacy alone, it sure has potential to dent its competitor franchises.

The trial involved administering emicizumab to 35 patients and who were later randomized a further 18 to receive on-demand bypassing agents (BPAs) but no prophylactic treatment.

The hope was that the antibody would be able to cut the bleed rate by binding to activated factor IX

and factor X. This approach is designed to fill the role normally played by factor VII.

And now result data from the trial suggests that emicizumab has worked as hoped. The study also found it to clean up against the secondary endpoints. After a median of 31 weeks, almost two-thirds of patients were found to suffer no treated bleeds, and only 5% in the control group were similarly unaffected by bleeds.

A future reward potentially awaits Roche with the launch of this drug; an estimated peak sale of $5 billion a year is possible for emicizumab.

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