GlaxoSmithKline/Human Genome's Benlysta delayed, as US FDA pushes back PDUFA target

UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) and the USA’s Human Genome Sciences (Nasdaq: HGSI) revealed on Friday that the US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from December 9, 2010 to March 10, 2011.

The news, which sent HGS’s shares down 6% to $25.60 on Friday, comes as something of a surprise as just last month an FDA advisory panel voted 13 to two to recommend that the FDA approves Benlysta for this indication. However, a Sanford Bernstein warned at the time that the FDA could pose a delay to consider risk management options (The Pharma Letter November 17). The advisory panel voted 10 to five that there was substantial evidence the drug was effective - and substantially relieved pain and flare-ups caused by lupus - and 14 to one that it was safe, despite a slight rise in deaths and suicides among those receiving the drug compared to a placebo.

After the FDA Arthritis Advisory Committee met on November 16 to consider the Benlysta BLA, the FDA requested some additional information from HGS, which has been submitted, the companies said in a press statement, but did not specify what the agency was calling for.