Lilly ADHD Drug May Need New Trial
Eli Lilly & Co. said regulators may require a new trial for its experimental treatment for attention deficit hyperactivity disorder, a drug Wall Street has been counting on to win approval and become a big seller.
A Lilly spokesman said the Food and Drug Administration has deemed the drug, called Strattera, “approvable.” But he said final approval was contingent on the firm providing the FDA additional clinical trial data or analyses that might require a new trial.
The Indianapolis firm, which has been plagued by manufacturing problems that have held up FDA approvals for drugs to treat osteoporosis and schizophrenia, sought U.S. approval for Strattera in October.
Separately, Lilly & Co. received a grand jury subpoena last month from the Justice Department for allegedly marketing its Evista osteoporosis drug for unapproved uses, the company said in a regulatory filing.
Lilly shares rose $2.24, or 4%, to $58.24 in NYSE trading.
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