Financial Times on Lilly's Xigris problems
USFDA panel split on Lilly sepsis drug
By Adrian Michaels in New York and Victoria Griffith in Boston
Published: October 17 2001 00:30 | Last Updated: October 17 2001 00:35
Eli Lilly on Tuesday suffered a setback in efforts to have its breakthrough treatment for sepsis, or septic shock, approved by regulators.
An advisory panel to the US Food and Drug Administration was split over whether to recommend approval of the drug, originally known as Zovant and now called Xigris.
The FDA, which normally follows panel advice, could be prompted to delay approval after 10 of 20 panel members voted against.
Xigris has already been held up by the FDA once this year over manufacturing quality concerns. In addition, Tuesday's panel hearing had been delayed by the September 11 terrorist attacks. The drug was hailed by some analysts as the most exciting expected approval this year.
Sepsis is an often fatal condition that affects 1.5m people worldwide.
Tuesday's split decision surprised analysts, who had expected Xigris to be recommended. Some panel members urged more clinical studies, unconvinced that the drug had demonstrated a clear benefit. Lilly says it saves the lives of a significant number of patients.
The FDA could decide to limit severely the number of situations for which the drug's administration is approved.
Such limitations, stated on the drug's label, could mean that as few as 25 per cent of sepsis patients would be prescribed the drug, so cutting into Xigris sales.
"Restrictive labelling often does not have the desired effect, but in the case of Xigris it may, because of stringent enforcement by hospitals due to its high expected cost," said Barbara Ryan, analyst at Deutsche Banc Alex Brown.
Lilly had been hoping for more positive news from the panel and its shares may come under further pressure on Wednesday. The company has already suffered at the hands of investors this month. It scaled back earnings forecasts in response to competition from generic equivalents to Prozac, the anti-depressant drug. |
