Fighting off a flank attack in the courts by attorneys for rival Shire, Roche says it was flagged for the FDA’s inside regulatory track for emicizumab (ACE910), a new drug for hemophilia A.
The Swiss pharma giant says the FDA has now set February 23 as its deadline for a decision on this drug, lopping four months off the process in recognition of its potentially game-changing status in the field.
This is one of Roche’s top drugs, and also one of its most puzzling challenges. In Phase III the drug hit the big goal, providing a statistically significant drop in the number of bleeds among patients with inhibitors to factor VIII. And one of the secondaries was a reduction in bleeds recorded in an “intra-patient comparison in people who had received prior bypassing agent prophylaxis treatment.”
Some of the peak sales estimates for this drug run up to around $5 billion, which Roche could really use as its three big franchise therapies lose patent protection.
But researchers have also recorded several cases of blood clots — two patients had thromboembolic events and two patients developed thrombotic microangiopathy, or TMA — among patients taking the drug.
Shire, which is likely to lose market share along with Novo Nordisk if the drug is approved, has lashed out at Roche for shifting the blame for the clots from emicizumab to bypassing agents, including its own.
Shire also claims that Roche has been misleadingly offering a look at “treated bleeds” — a secondary endpoint — instead of the “number of bleeds over time,” originally laid out as the primary endpoint in HAVEN 1. And by blaming thrombotic incidents on its bypassing agent, Shire adds, it’s been damaged.
That can now all be sorted out at the FDA, particularly if they require an outside panel review with a public analysis of the data.
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