The US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission instead of the usual ten months. Consequently, a response from the FDA should be out in the fourth quarter of 2010 (projected target date: December 9, 2010).

The Biologics License Application (BLA) seeking marketing approval for the lupus candidate in the US was filed by the companies on June 9, 2010. The Marketing Authorization Application (MAA) seeking approval for Benlysta in Europe was also filed with the European Medicines Agency (EMA) in the same month (June 4). The drug is under review in Europe.

The application includes data from two late-stage trials, BLISS-52 and BLISS-76. Both double-blind, placebo-controlled, multi-center studies evaluated the efficacy and safety of Benlysta in combination with the standard of care against placebo plus standard of care in seropositive SLE patients. The studies evaluated a total of 1,684 patients.

Our Recommendation

Human Genome currently has a Zacks #3 Rank, which translates into a short-term Hold rating. We are also Neutral on the stock in the long term. The long-term stability offered by the potential approval of Benlysta is the main reason behind our Neutral stance on the stock. The stance indicates that the stock is expected to perform in line with the US equity market over the next 6+ months. We advise investors to retain the stock over the time period.