FDA plans to review lupus drug

FDA plans to review lupus drugThe companies said this week that regulators should reach a conclusion by early December on an experimental lupus drug made by Human Genome Sciences and GlaxoSmithKline.

The Food and Drug Administration is conducting a priority review of Benlysta as a treatment for systemic lupus. Benlysta would be the first new lupus to reach the market in more than 50 years, if at all it gets approved.

Priority reviews are given to products by FDA which could significantly improve existing treatments or that provide hope for an illness for which no treatment has been approved.

The declaration was made two months after the drug developers submitted late-stage data for Benlysta, also known as belimumab, to the regulator.

The companies informed that FDA has decided to take action regarding the Benlysta application on Dec. 9.

The fast-track review being considered by the FDA is good on two counts. The drugmakers will not only be able to book sales earlier than some analysts had expected but also priority status drugs have a higher chance to win a green light from the regulator.

It is the FDA's discretion to review designation for drugs which offer major advances in treatment to provide a treatment where a good enough therapy does not exist.