GlaxoSmithKline has withdrawn a supplemental New Drug Application in the USA for its benign prostatic hyperplasia treatment Avodart though the move is not connected with any safety issues.

The company has temporarily pulled the sNDA for Avodart (dutasteride) for prostate cancer risk reduction and a GSK spokeswoman told PharmaTimes World News that the move has been prompted by an “administrative error”. She stressed that the withdrawal is not the result of new findings related to safety or efficacy.

The spokeswoman added that GSK expects to resubmit the file shortly, but declined to give any specific timeline. The company added that a review of the European filings will begin once the same update has been provided to the continent’s regulatory agencies.

Avodart is a pretty good earner in BPH for GSK and third-quarter sales reached £131 million, up 14%, However, getting approval in prostate cancer would be lucrative, as is the second most common cause of cancer death in men.

The firm presented promising data from a trial in April which showed that the drug cut the risk of prostate cancer in men aged between 50 and 75 with elevated levels of prostate specific antigen, a marker for the disease, by a significant 23% over four years. That study also showed no increased risk from more aggressive tumour types in patients given Avodart, as seen with Merck & Co’s baldness drug Propecia (finasteride) when it was tested for prostate cancer prevention in 2003.

Pandemrix one-dose effective in children
Meantime, GSK also announced new results from an ongoing trial assessing the use of its swine flu vaccine Pandemrix in children and adolescents aged 3 to 17. The study shows that after the first dose of adjuvanted H1N1 vaccine, “a strong immune response was demonstrated in all age groups [which] exceeded the immunogenicity criteria, as defined by international licensing authorities for a pandemic influenza vaccine”.

All the participants received 3.75mcg of Pandremix, equivalent to the full adult dose and GSK also noted that over 40 million doses have been distributed.