WASHINGTON — An advisory committee today recommended Food and Drug Administration approval of a drug that can help alleviate baldness, although some members expressed skepticism over how many people would benefit.
The unanimous recommendation by the five-member committee is viewed as a forerunner of formal FDA approval in a few months.
The Upjohn Co. said 40% of the participants in a yearlong study showed "moderate to dense" hair growth with the use of minoxidil, but panel members said the drug's success rate may be less.
The Food and Drug Administration now must meet with Upjohn officials before a final recommendation is sent to the commissioner.
$45 in Canada
The drug, trade-named Rogaine, would be available within a couple of months after final approval.
Upjohn officials said the drug costs the equivalent of $45 for a month's supply in Canada, where it has been on the market since last October under the name Regaine. The officials declined to say how much it would cost in the United States.
Upjohn began testing the hair-restoring properties of a lotion form of minoxidil in 1982, when they found that people taking the drug in pill form for high blood pressure were experiencing an unusual side effect--increased hair growth.
The tests of Rogaine involved 2,326 participants aged 17 to 49 in several cities. Upjohn said many participants experienced hair growth and "40% of the patients demonstrated readily observable hair growth" between four months and a year after beginning use of Rogaine.
Young Respond Quickest
Younger men and those with the shortest history of baldness showed the greatest response.
Dr. Robert Stern, a panel member and associate professor of dermatology at Beth Israel Hospital in Boston, said his review of published literature on Rogaine suggested only one in seven people would have a substantial enough increase in hair to affect their appearance.
"You cannot predict on any patients whether they will have an advantageous experience with the drug," he said.
However, the panel voted by consensus that there was enough proof of Rogaine's efficacy, with no side effects, to recommend it be marketed.