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Human Genome Lupus Medicine Could Be Unsafe

The experimental lupus drug Benlysta, manufactured by Human Genome and GlaxoSmithKline, may not be safe, according to U.S. regulators.

Benlysta’s risks include suicide, infection and cancer. What’s more, data showing the drug was effective lacked “robustness,” according to the FDA.

According to Bloomberg:

“The FDA’s recognition of an unmet medical need for more lupus therapies may outweigh agency staff reviewers’ safety and efficacy concerns ... The companies expect a decision on approval by Dec. 9”.

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