FDA is embarking on a safety review of the asthma drug Xolair. At issue: interim findings from a five-year observational study, which suggest an increase in the number of heart problems and strokes in Xolair patients, the agency said. But it's not recommending any immediate changes to prescribing information for the drug and isn't advising patients to stop taking it. Co-marketed in the U.S. by Roche/Genentech and Novartis, Xolair brought in $517 million last year.
The study is tracking 5,000 Xolair patients and 2,500 patients not using the drug; it won't be complete until 2012. Interim data suggested a "disproportionate increase" in cardiovascular problems, FDA said, but because patients aren't randomized to particular treatment groups, the difference could be due to "underlying risk factors."
In other words, as Genentech and Novartis point out, Xolair patients might just have more health problems to begin with. Other clinical data on the drug doesn't indicate an increased risk of these problems, they said.
FDA has been alerting the public to safety reviews earlier in the process these days. Rather than waiting till the data is fully sliced, diced and parsed, the agency sends out "early communications" to let people know that safety reviews are underway. In some cases, the agency later reports that the review found no safety problems. For this one, we'll have to wait and see.