Antibody developer Eli Lilly’s Xeomin drug trial was placed on temporary hold on Thursday, Oct. 11, to gather more data to determine whether it has a serious side effect.
The Wall Street Journal first reported that the incidence of allergic reactions was twice that of competitive injectors of similar drugs. A press release from Lilly said the data in the study are preliminary, but the newspaper called it an unexpected safety spike. A Lilly spokesman said the company has a plan to restart the study if they can review the data at their discretion.
Eli Lilly and Co. said in a press release Friday that the study will continue and that the data in the study are preliminary, but added, “The company believes that if results from the study are sufficiently positive that the data could support the use of the anticoagulant Xeomin as an emergency treatment for hemorrhagic shock in hospitals using IV receiving IV access.”
The biopharmaceutical company also said in a statement that the drug’s primary objective, defined as a reduction in thromboembolic events, was met. The trial, however, tested a planned use, that is that patients would use the drug to prevent organ and tissue damage in patients with conditions such as cardiac failure and stroke, rather than directly treating symptoms.
The study results showed a 49% reduction in thromboembolic events among patients who received the drug, compared to 21% in the other group that got the standard-of-care injection. The primary purpose of the trial was to determine how the medicine decreases the rate of thromboembolic events in patients after surgery or with thromboembolic attacks, and there were no significant differences in the percentage of patients who died and patients who needed an emergency infusion.
There were 3,904 patients in the study. The rate of thromboembolic events was higher in the group receiving the drug than among patients who received the injection, likely because there was an overuse of a common element in the treatment, Dr. Shigeo Noshimada, director of Japanese scientific division at Brigham and Women’s Hospital in Boston, told the newspaper.
He also called the amount of the observed number of adverse reactions “unexpected.”
The Wall Street Journal reported that patient safety information on labels that describe this event, unrelated to safety concerns or efficacy in its primary objective, and may limit its use, are available for Xeomin.
The drug is a piece of equipment that pumps and injects a drug on the patient’s neck that is intended to induce bleeding on the brain for medical conditions. Thromboembolic events or bleeding require life-saving intravenous fluids. The drug will be offered in Europe, Japan and several other areas of the world.
In 2015, CNN reported that Xeomin garnered an outpouring of backlash from angry customers, who swore off the drug and said they felt misled by a company that advertises on TV during “Game of Thrones” and “South Park.” One customer even went as far as to create a complete makeover of their home.