Pharma Strategy and Competitive IntelligenceBusiness intelligence in a biotechnology world

Johnson and Johnson’s Ortho Biotech has informed the FDA of preliminary safety findings from a clinical trial conducted in Germany investigating the use of Procrit (epoetin alfa) to treat acute ischemic stroke. The clinical trial utilised doses of Procrit that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product.

The trial was designed to determine whether the drug could help patients who have had an acute ischaemic stroke, an unapproved indication in both the EU and US.

However, it seems that the results showed that over ninety days after the start of the trial, there were more deaths in the group of patients who received Procrit compared to patients who received the placebo (16% versus 9%). Approx. half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received Procrit compared to 1% of patients in the placebo group.

Submission of additional data to the FDA is expected within the next few weeks. Once a review of these data is completed, it is likely that the FDA will communicate their conclusions and recommendations to the public. The finding of increased mortality in patients receiving Procrit in the German trial would suggest the need to closely monitor patients enrolled in other ongoing trials for adverse outcomes and to evaluate whether the potential benefits for enrolled patients outweigh the risks in these trials.

More information can be found on the FDA’s Center for Drug Evaluation and Research (CDER) site.

Erythropoeitin stimulating agents (ESA’s) have had a chequered history over the last year with a number of safety concerns arising to the authorities attention, including whether or not they stimulate tumour growth and increase the risk of death.