Follea Submits to the US FDA a De Novo Application for the Minoxidil Response Test
Follea International, Ltd. announced that they have submitted to the U.S. Food and Drug Administration (FDA) a De Novo application for a medical device – the Minoxidil Response Test.
The Minoxidil Response Test is a prescription device intended to be used by a physician as an aid in assessing the likelihood that a patient suffering from pattern hair loss will not respond to topical minoxidil therapy.
Minoxidil is the only topical drug approved by the US FDA for the treatment of male and female pattern hair loss (also known as androgenic alopecia).
While the safety of topical minoxidil has been established, the efficacy remains relatively low i.e., only 30-40% of patients respond following 4-6 months of daily treatment.
The Minoxidil Response Test helps identify the 60%-70% of patients that will not respond to minoxidil.
Since hair loss is progressive, it would be of great clinical utility if non-responders could be identified early and prescribed alternative treatment.
Daniel Haffid CEO of Follea recently stated, “Currently, patients suffering from androgenetic alopecia have to wait a minimum of 4-6 months to observe response to topical minoxidil.
Frequently, the results are not satisfactory and patients continue to suffer from progressive hair loss.
The Minoxidil Response Test, once cleared, would arm physicians with a rapid diagnostic (24 hours) that will impact each patient’s treatment plan. Eliminating time wasted on ineffective treatments; thus, more likely to prevent additional hair loss”