GSK set for FDA approval?

Good news for GSK, who are currently awaiting review of their cervical cancer drug, Cervarix, by the US Food and Drug Administration, as a posting has appeared on the FDA website which suggests a favourable outlook. 

The memo, which appeared on the site earlier today, surfaces ahead of a Vaccines and Related Biological Products Advisory Committee meeting scheduled for Wednesday and suggests the jab is "expected to provide a significant public health benefit to girls and women between the ages of 10 and 25 years."

Its a good news Cervarix and GSK alike, who have long struggled for approval in the US, despite being approved in 97 countries already, including the EU states. It has certainly been a long road, which culminated in thee FDA asking GSK for more date on the drug in 2007, which the UK-based pharmaceutical company duly provided.

Now, according to this leaked memo, there is a "substantial database" which contains information on somewhere in the region of 57,000 females aged 10 and over. According to GSK's data doses of Cervarix that have been distributed up until May 2009 exceeded the seven million mark, with "no safety concerns having been detected in post-marketing surveillance."

GSK, the world's second-largest pharmaceutical and research-based company already offers a wide portfolio of pharmaceutical products covering anti-infectives, central nervous system, respiratory, gastro-intestinal/metabolic, oncology, and vaccines products. The firm is hoping that a FDA approval of Cervarix will help prevent cervical cancer caused by human papillomavirus types 16 and 18 in the 10 and 25 years age bracket.

According to their FDA, there are still plans to evaluate long-term safety of the vaccine, "specifically the potential occurrence of autoimmune disorders and pregnancy outcomes" before full approval can be granted.

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