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.

In those patients that had received treatment with inhibitors, there was a 68% reduction in the number of treated bleeds.

The data firmly plants Roche at the head of the pack in treating patients with haemophilia and the company plans to file for wider indications for the treatment. It currently has approval for use alongside factor VIII inhibitors but could now see this extended to patients not receiving such treatment.

"These new pivotal data show that Hemlibra controlled bleeds in people with haemophilia A, while offering the flexibility of less frequent subcutaneous dosing options," said Sandra Horning, Roche’s Chief Medical Officer and head of Global Product Development. "With this data, we now have positive results from all four of our Phase III trials that reinforce the overall efficacy and safety of Hemlibra and its potential to improve care for all people with haemophilia A."

Analysts predict that success in the area could see the drug rake in between $4 billion and $5 billion in annual peak sales; this represents an essential success for Roche, as its major oncology drug franchises face increasing competition.

It also moves the narrative on for Hemlibra, after five deaths in trials for the drug there was a risk of perceived risks of the drug hindering sales, though Roche moved quickly to state that none of the deaths were linked to the drug’s use.

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