Dutasteride May Be Approved Soon

October 22, 2001

According to a recent presentation by GlaxoSmithKline, the company researching Dutasteride, there is good news coming down the pike for hair loss sufferers. The "Lehman Brothers" presentation on October 10th in London focused on Dutasteride and it's use and marketing in Benign Prostatic Hyperplasia (BPH). Although the study did not reference hair loss results or studies directly, it did discuss the marketing of Dutasteride for BPH, which helps us have an idea of when we will be able to start using it 'off-label.'

For those who are not familiar with Dutasteride, it is a medication similar to Finasteride which prevents the hormone Testosterone from being converted to DiHydroTestosterone (DHT). Although the exact mechanism for hair loss is not known, it is known that there is a direct correlation between DHT levels and hair loss. Reducing DHT leads to a reduction of hair loss and regrowth of hair. The amount of hair regrown depends varies by individual.

Propecia (Finasteride) inhibits one of the two types of enzymes that block the formation of DHT. Propecia blocks roughly 70% of DHT production in men and in long term studies has shown to regrow hair in the majority of men and halt hair loss in nearly all men who use it. How much hair is regrown varies by individual. A small percentage of men see great regrowth, while the majority who see regrowth see moderate or minimal regrowth of hair lost. Results are best for recent loss. According to Glaxo's presentation, Dutasteride has less variation in the amount of DHT reduced than Propecia and reduces at least 95% of DHT.

Dutasteride is in development by GlaxoSmithKline and is currently in the final stages of the approval process for BPH. It's status in hair loss use seems to be the subject of some rumors. Glaxo did phase II FDA trials in the US (small scale human trials, generally less than 100 people). After the trial, instead of proceeding to large scale phase III trials, Glaxo stopped trials for hair loss. Usually, this means that the medication didn't work. However, multiple sources involved in the trials have confirmed that not only did the medication work as expected, but that the results were surprisingly good and did exceed Propecia's results. There have been many rumors as to why the trials did not continue. Some rumors have included the merger between Glaxo and SmithKline, higher incidence of side effects than Propecia (unconfirmed), and poorer than expected sales of Propecia in the US. There seem to be no end to rumors including that large scale trials are still proceeding for hair loss in Europe. The company did, however, complete all phases of the clinical trials for treatment for BPH and submitted it to approval to the FDA for that use.

Following the completion of all three phases of clinical trials, the company analyzes all of the data and files an NDA with FDA if the data successfully demonstrate safety and effectiveness. The NDA must contain all of the scientific information that the company has gathered. NDAs typically run 100,000 pages or more. By law, FDA is allowed six months to review an NDA. In almost all cases, the period between the first submission of an NDA and final FDA approval exceeds that limit; the average NDA review time for new molecular entities approved in 1998 was 11.7 months.

Once FDA approves the NDA, the new medicine becomes available for physicians to prescribe. The company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines, FDA requires additional studies (Phase IV) to evaluate long-term effects.

The Lehman Brothers presentation did not present any spectacular information other than a better timeline of approval for BPH. According to the presentation, a New Drug Application (NDA) was submitted with 1 year results of large scale studies in the 4th quarter of 2000. A Marketing Approval Application (MAA) including 2 year large scale results was submitted in the 3rd quarter of 2001. According to their presentation, they expect the NDA to be approved in the 4th quarter of this year. The FDA's investigators meetings will be held in November of this year, so we can probably expect to hear an approval notice for Dutasteride in November or December of this year. It usually takes 1-3 months for drugs to be available after FDA approval as the manufacturer begins mass production and distribution. An unverified rumor recently stated that the medication would be available as soon as December in Europe. As far as Regrowth knows, the only people who know when, how, and whether Dutasteride will be available for hair loss are the higher ups at GlaxoSmithKline. However, due to the laws of our great country, a physician may prescribe any medication to his patient for 'off label' use if he so chooses, so once Dutasteride is available, it will be possible to get the medication if you wish to take it.

Bottom Line: Look for Dutasteride for treatment of BPH to be announced prior to the end of the year and available for sale sometime after the beginning of the year if everything goes according to schedule.

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