Parker Waichman LLP is Reviewing Hemlibra Fatality Claims Nationwide
According to a news report by biocentury.com, pharmaceutical corporation Genentech Inc. has reported five deaths in patients taking its new hemophilia drug.*
In a statement released March 27, the Hemophilia Federation of America said it had been notified by Genentech, a unit of Roche, that five people taking the drug Hemlibra had died. Hemlibra was approved by the U.S. Food and Drug Administration in November 2017 to treat adults and children with hemophilia A. It is a bispecific factor IXa- and factor X-directed antibody that can be injected to prevent bleeding episodes in patients with hemophilia A with factor VIII inhibitors.
Genentech indicated that one of the reported deaths occurred in 2017 during the Hemlibra clinical trial called Phase III HAVEN 1. This patient reportedly suffered a severe rectal hemorrhage, which led to the patient’s death. Genentech said in a statement that it had investigated the incident and concluded the patient’s death was not related to treatment with Hemlibra.
Little information has been shared by Roche or Genentech about the four additional patient deaths, other than that one occurred in 2016, one in 2017, and two in 2018. The lack of information is likely because all four of these patients were taking ‘Hemlibra’ under an expanded access program (also known as a “compassionate use” program). Expanded access means the drug was experimental at the time (not approved by the FDA), and the patient was taking it outside of a clinical trial. Though it has not shared causes of death for these patients, Genentech has maintained these four deaths were also not caused by Hemlibra.
In addition to the deaths recently reported by Genentech, Hemlibra is associated with other serious adverse events. As approved, the Hemlibra drug label contains a Black Box warning (the strongest warning for a drug label) about adverse events observed during clinical trials. Patients in clinical trials taking ‘Hemlibra’ with certain other medications — activated prothrombin complex concentrates (aPCCC) used to control or reverse a bleeding event — developed a condition called thrombotic microangiopathy. Thrombotic microangiopathy is a disease in which blood vessels in some of the body’s most vital organs, like the brain and kidneys, become damaged. The condition can be fatal.
In the case of the patient who died from a rectal hemorrhage, ‘Hemlibra’ adverse events overlapped. As explained in a statement from Roche to the European Hemophilia Association, this patient suffered a serious bleed while taking Hemlibra during a clinical trial and was given an activated prothrombin complex concentrate to reverse the bleed. The patient then developed thrombotic microangiopathy, and the aPCCC was withdrawn. The bleeding event could then not be controlled, and the patient died.
Genentech is headquartered in San Francisco and has been a subsidiary of Roche since 2009. It manufacturers numerous well-known prescription medications, including Boniva, Klonopin, and Tamiflu.
About Roche and the Hemlibra Drug
Roche is a multinational healthcare company headquartered in Basel, Switzerland. ‘Hemlibra’ represents an expansion into the hematology market for Roche, which is already known for several drugs used to treat blood cancers. Its oncology drugs Rituxan, Avastin, and Herceptin are near patent expiration, and it is thought Roche introduced Hemlibra to try to bridge the anticipated revenue gap created when those drugs lose patent protection.
Reuters reports that Hemlibra costs approximately $450,000 a year, and analysts believe the drug can soon hit $5 billion in annual sales. In light of news breaking about the five patient deaths, Roche’s shares dropped, according to a report by Reuters. Just as Roche was coming off a legal patent victory in Japan concerning ‘Hemlibra’, its shares dipped 2 percent by March 28.
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If you or your family member has been taking a Hemlibra and unexpectedly passed away, contact our law firm today for your free consultation by filling out our online form or by calling 1-800-YOURLAWYER (1-800-968-7529).
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