After hemophilia patient groups this week posted information about deaths during treatment with Roche's Hemlibra, the drugmaker confirmed that five patients using the drug have died. None of the deaths was determined to be linked to the drug, a Roche spokesperson said.
One patient who received Hemlibra under a compassionate use program—before it won FDA approval—died in 2016, the company said. Two died in 2017—one under a compassionate use program and one in the phase 3 Haven 1 trial. This year, two adults using the treatment died.
"Again, the treating physician’s assessment for both patients was that the cause of death was unrelated to Hemlibra," the company spokesperson said. Hemlibra won U.S. approval back in November.
While cautioning that it's too early to tell what the news will mean in the long run, Jefferies analyst David Steinberg wrote that the deaths could reignite safety concerns after news of the first death last year and other serious adverse events in clinical testing.
"Additionally, we’d note that some experts still do not fully understand the mechanism behind Hemlibra, which could potentially impact use in non-inhibitor patients who are generally well controlled on [Shire]’s Advate," he added.
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The Hemophilia Federation of America and the National Hemophilia Foundation each posted limited information about the deaths on their respective websites, providing a Genentech medical support number for patients to call with questions.
Analysts have big expectations for Hemlibra; the drug led a recent report by Clarivate detailing pharma's top launches for 2018. According to the firm, analysts predict the drug will reach just over $4 billion in sales by 2022. Jefferies analysts have previously predicted $5 billion in peak sales.
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For Roche, the launch is important as it comes as Roche faces a growing biosimilar threat to top blockbusters Rituxan, Herceptin and Avastin.
Roche said it reported the deaths promptly. "We were deeply saddened to learn about these deaths and take all reports of death and safety events very seriously," the drugmaker said in a statement. "For each report, we followed our safety assessment and reporting processes to ensure prompt evaluation of the event and continued broader patient safety."