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FDA staff post review of GlaxoSmithKline's Cervarix ahead of meeting
  by Anna Bratulic
September 04, 2009
FDA reviewers stated that GlaxoSmithKline's Cervarix has a favourable risk/benefit profile and should "provide a significant public health benefit" to girls and women between the ages of 10 and 25 years, according to documents posted on the agency's website. A panel of advisors scheduled to meet on September 9 will consider whether to recommend approval of the vaccine, which is intended to prevent cervical cancer and certain other diseases caused by human papillomavirus types 16 and 18 in that age group.
Agency staff said the vaccine's efficacy was assessed in 19 778 girls and women from 15 to 25 years of age, with follow-up of up to 6.4 years after vaccination. Reviewers remarked that the vaccine has an "excellent safety profile," but indicated plans to continue to monitor Cervarix's long-term safety in two large post-marketing studies. The FDA briefing document noted that data from a clinical safety database showed a "numerical imbalance" in the rates of miscarriage among women given Cervarix, compared with those in a control group, but that an independent statistical analysis concluded the findings "do not establish a causal relationship."
Matrix Corporate Capital analyst Navid Malik forecast that Cervarix, which generated revenue of 125 million pounds ($232 million) last year, could reach peak annual sales of 1 billion pounds ($1.6 billion) by 2012 with FDA approval.
Reference Articles
Glaxo girls vaccine backed as Merck eyes boys? market - (Bloomberg)
US FDA staff note miscarriages in Glaxo vaccine data - (CNBC)
Vaccines and Related Biological Products Advisory Committee meeting Cervarix briefing document (pdf) - (FDA)
US watchdog eases way for GSK vaccine - (Financial Times)
FDA says Glaxo vaccine blocks cancer-causing virus - (The Washington Post)
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