By S. Sutter
A negative view by Swedish authorities appears to have been the last nail in the regulatory coffin for GlaxoSmithKline PLC’s global pursuit of a prostate cancer prevention indication for Avodart (dutasteride).
The company announced March 23 that it will no longer pursue global approval of the 5-alpha reductase inhibitor for prostate cancer risk reduction and will seek removal of the claim in countries where it has been approved. It had received input from Sweden’s drug agency the month before.
Dutasteride is approved for the treatment of benign prostatic hyperplasia in more than 90 countries. In the U.S., the indication includes improving BPH symptoms, reducing the risk of urinary retention and reducing the need for BPH-related surgery.
GSK sought a cancer risk reduction claim based on results from the REDUCE trial in 8,231 men at heightened risk for prostate cancer. Such a claim would have been the first for a prostate drug in the U.S. and offered GSK a huge opportunity to expand dutasteride’s market before the onset of generic competition, expected in 2015 at the latest.
However, the indication’s viability in the U.S. was largely quashed by a by an FDA “complete response” letter in January.