Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genentech's asthma drug Xolair is to carry a new label warning patients of a potentially lethal allergic reaction in a response to new FDA labeling guidelines.
Subscribe to our email newsletter
The FDA originally proposed its “black box warning” about anaphylaxis back in February. The label’s final wording has only recently been announced.
Xolair, which is known generically as omalizumab, is approved to treat adults and children over the age of 12 for moderate to servere asthma.
The drug’s previous label warned that anaphylaxis, an inflammatory reaction, occurs in roughly one in 1,000 patients. The new label now states the figure is two out of 1,000 patients taking the medication.