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TRENTON, N.J – British drugmaker (NYSE: GSK) said Monday it is temporarily withdrawing its application for U.S. approval of a drug to prevent prostate cancer.
The drug is already sold under the name Avodart, for treating symptoms of an enlarged prostate.
The company, which maintains its U.S. headquarters in Research Triangle Park, N.C., was seeking approval for a new use, reducing risk of prostate cancer, after research showed Avodart could reduce that risk by about 25 percent.
GlaxoSmithKline said it wants to provide an update to its application to the Food and Drug Administration. Those applications generally include thousands of pages of data on testing results and characteristics of an experimental drug.
The company said that its decision is not due to any new findings related to safety or effectiveness of Avodart.
GlaxoSmithKline, the world’s No. 2 drugmaker, said it expects to resubmit its application to the FDA shortly.
The company said it will submit the same update to regulatory agencies in the European Union, after which their review of the proposed new use will begin.
In April, doctors reported that a large international study had found Avodart, known chemically as dutasteride, reduced chances of men being diagnosed with prostate cancer by 23 percent after four years’ use.
Whether many men will start taking the drug preventively is unclear, given that it costs nearly $4 per daily pill and insurers may be hesitant to cover that cost.
However, last February health experts recommended that men who are regularly getting screened for prostate cancer consider taking Avodart or a competing drug, Merck & Co.’s Proscar, which also is available in a generic version called finasteride.
Every year, tens of thousands of men get results from prostate cancer screening indicating a possible problem, but then biopsies come back negative, leaving them worried and unsure what to do.