Novartis pauses autoimmune cell therapy studies after deaths, WSJ reports
Novartis paused eight clinical trials of an experimental therapy targeting autoimmune and neurological disorders in late August, after three patients died, the Wall Street Journal reported on Tuesday. The Swiss pharmaceutical company temporarily halted the studies after learning of three fatal cases of a severe immune response, the report said, citing a spokesman. It wasn’t immediately clear when…
Novartis has halted eight clinical trials of an experimental therapy targeting autoimmune and neurological disorders following the deaths of three patients, according to a report by the Wall Street Journal. The Swiss pharmaceutical company temporarily suspended the studies after discovering three fatal cases of a severe immune response, the report stated, citing a spokesman.
The exact timing of the deaths was not immediately clear. The experimental treatment, known as chimeric antigen receptor T-cell or CAR-T, modifies a patient's immune cells to recognize and destroy specific targets. Novartis is conducting a thorough review of the safety events, describing the fatal immune response as a known risk in CAR-T therapies.
The company is collaborating with independent safety boards overseeing each paused study and sharing its findings with regulators, the spokesman told the newspaper. Bristol-Myers Squibb also paused similar trials of its CAR-T treatment for autoimmune disorders as a precautionary measure, WSJ reported. Neither Novartis nor BMY provided immediate comment to Reuters.
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