(Bloomberg) -- Sanofi-Aventis SA, whose weight-loss
pill was rejected by U.S. regulators last month, may have
mismanaged the drug's development by promising too much and
failing to heed safety concerns in patient studies.
The company didn't follow up on thousands of patients who
dropped out of clinical tests for Zimulti, the obesity treatment,
studies of the drug show. That left Sanofi unable to answer U.S.
regulators' questions about side effects, according to documents
the Food and Drug Administration released in June. Two weeks
before the FDA review, Chairman Jean-Francois Dehecq told
Sanofi's annual meeting he expected a ``positive outcome.''
Read more at Bloomberg Exclusive News
pill was rejected by U.S. regulators last month, may have
mismanaged the drug's development by promising too much and
failing to heed safety concerns in patient studies.
The company didn't follow up on thousands of patients who
dropped out of clinical tests for Zimulti, the obesity treatment,
studies of the drug show. That left Sanofi unable to answer U.S.
regulators' questions about side effects, according to documents
the Food and Drug Administration released in June. Two weeks
before the FDA review, Chairman Jean-Francois Dehecq told
Sanofi's annual meeting he expected a ``positive outcome.''
Read more at Bloomberg Exclusive News
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