Eli Lilly has decided to withdraw its sepsis treatment Xigris after a study showed no benefit in taking the drug which has been on the market for about ten years.
The US major is pulling Xigris (drotrecogin alfa) from all markets worldwide following results of the PROWESS-SHOCK study, which did not meet the primary endpoint of a statistically-significant reduction in 28-day all-cause mortality in patients with septic shock. The 1,696-patient trial began in March 2008 as a condition for continued market authorisation in Europe (it was approved here in 2002 and in November 2001 in the USA).
Timothy Garnett, Lilly's chief medical officer, noted that "while there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile…and its continued use". He added that "we believe the original Xigris approval was appropriate and these recent results were quite unexpected," saying "a contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past ten years".
Xigris was touted as a blockbuster when it was launched but use of the drug was reserved for only the sickest patients. Sales reached $104 million last year for a treatment plagued with safety concerns and Lilly noted that it expects to incur a charge in the fourth quarter related to the Xigris withdrawal in the region of $75-$95.0 million.
Zyprexa copies hit US market
Meantime, the first generic versions in the USA of Lilly's blockbuster antipsychotic Zyprexa (olanzapine) have been launched by Teva Pharmaceutical Industries and Dr Reddy's Laboratories.
At the weekend, the patent expired on the schizophrenia and bipolar disorder drug across the Atlantic, where it had annual sales of $3.2 billion ias of September, based on IMS data. The US Food and Drug Administration has approved copies of olanzapine from Dr Reddy's and Teva, which both have 180-day exclusivity, and from Apotex and Par Pharmaceuticals.
Keith Webber, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, said "the approval of generic olanzapine offers greater access to a widely-used treatment for mental illnesses". He added that "having affordable treatment options is good for patients with long-term illnesses that must be carefully managed."