New Target Date for HGSI's Benlysta - Analyst Blog

Recently, the US Food and Drug Administration (FDA) extended the review period for potential blockbuster lupus drug candidate, Benlysta, co-developed by Human Genome Sciences Inc. (HGSI) and GlaxoSmithKline plc (GSK), by three months.

The US regulatory agency, which was to decide on Benlysta's fate on December 9, 2010, will do so on March 10, 2011. The partners are seeking approval for Benlysta as a treatment for patients suffering from systemic lupus erythematosus (SLE).

The necessity to extend the review period arose as the agency, following the FDA advisory panel meeting on November 16, 2010, felt that it required additional data on the candidate. Human Genome has already submitted the additional information.

We remind investors that the FDA had originally decided to review the Biologics License Application (BLA), seeking marketing approval for the lupus candidate in the US, on a priority basis. The BLA was filed on June 9, 2010.

The application included 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.

An advisory panel of the FDA met on November 16 to discuss the BLA. The Arthritis Advisory Committee voted 13-2 in favor of approving Benlysta for treating SLE.

In addition to asking the panel to discuss the efficacy data, the FDA had asked the panel to discuss the safety profile of the drug as well. The panel was asked to concentrate on the safety signals of infection, malignancy, suicidality and mortality imbalance favoring placebo over Benlysta.

Apart from that, the panel was also asked to weigh the risks of using Benlysta in combination with other immunosuppressive agents. Following the panel meeting, the FDA asked for additional information before coming to a final decision on the candidate and hence delayed the approval.

Benlysta is also under review in Europe. The Marketing Authorization Application (MAA) seeking approval for Benlysta in Europe was filed with the European Medicines Agency (EMA) in June this year.

Benlysta, if approved, would be the first new lupus drug to be approved in more than 50 years. Lupus is a potentially fatal autoimmune disease that is extremely difficult to treat.

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. We believe that the approval of the lupus drug will give a much-needed boost to Human Genome and will help drive the company to profitability.

The long-term stability offered by the possible approval of Benlysta is the main reason behind our ‘Neutral' stance on the stock. We expect investor focus to remain on the FDA's decision regarding Benlysta's approvability status.

 
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