Last Friday, the US FDA decided to keep the popular anti-baldness drug finasteride on the market, but now demanding its creators to add suicidal thoughts to your list of potential side effects.
Accordingly, on June 13, the FDA too endorsed Eli Lilly’s and Olcyiant by Incyte (baricitinib), the first treatment for alopecia areata, another form of baldness, which also has a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) for approval of the EMA. Alopecia areata is an autoimmune disease when the body’s immune cells attack hair follicles, while androgenic alopecia is a genetically determined pattern of hair loss.
These recent regulatory actions have drawn attention to the hair loss space, which is in high demand for treatments but has relatively few unique assets under development.
“Although we have seen new developments in the treatment of androgenic alopecia (AGA) in recent years, such as low doses of oral minoxidil and bicalutamide, effective management remains a challenge,” said Dr. Dmitry Wall, a dermatologist at Hair Restoration Blackrock in Dublin. .
Two established treatments, but there is room for more
Sold by Organon, Finasteride, sold as Propecia, had global sales of $ 292 million in 2005, according to GlobalData. The first generic was introduced in 2006. The latest FDA action came in response to a petition launched by a non-profit group called the Post-Finasterid Syndrome Foundation.
In 1988, the FDA approved minoxidil, a 2% topical solution, then offered by Upjohn under names such as Rogaine, for male use before being approved for women in 1991. A few years later, a stronger formula 5% was approved for men in 1997, with the female version receiving the green light in 2014. Upjohn merged with the Swedish company Pharmacia AB in 1995, before being acquired by Pfizer in 2002.
Almost a decade after the initial approval of minoxidil, the FDA approved the use of finasteride 1 mg tablets in 1997, a dihydrotestosterone blocker (DHT).
Finasteride is not currently approved for use by women and is contraindicated in pregnancy, according to the FDA’s Propecia label. However, there are cases of recommended off-label use among postmenopausal and sometimes premenopausal women, says Eva Proudman, a trichologist consultant and chairwoman of the Institute of Trichologists.
Finasteride and minoxidil are used in approximately 80% of patients, according to Proudman estimates, with a very positive result. Although side effects exist, she says her practice always discusses any safety concerns.
This is not the first time that the potential side effects of finasteride have been addressed. In 2012, the FDA requested an update to the drug’s label to include a mention of the risks of potential sexual dysfunction. According to the Merck label for Propecia, decreased libido and erectile dysfunction were reported in 1.8% and 1.3% of 945 treated subjects, respectively. The latest warning of suicide ideas comes after Merck’s internal records show that the company has known of more than 200 cases of depression since 2009. described in an exclusive issue of Reuters last February.
At the same time, it is important to note that hair loss can be a very emotional process for some and there are more factors around potential depression or suicidal thoughts than just the use of finasteride, says Proudman. As such, it is necessary to understand what these treatments can potentially do, she added.
In addition, some studies have shown that topical treatment with minoxidil is also potentially not for everyone. In a Pfizer-sponsored one-year follow-up study of 5% minoxidil solution from 2004, treatment shrinks the target area of hair loss in 62% of subjects, but remained unchanged in 35.1%. In the same study, 15.9% of subjects rated the treatment as very effective, but 20.6% found it to be moderately effective and 15.7% found no effect. The topical solution is intended for use in the crown and is not intended for the treatment of baldness or hair loss, according to Rogaine’s label.
Dutasteride, another DHT blocker sold by GSK under the name Avodart, has also been shown to be effective in reducing hair loss. But treatment has not yet been approved by the FDA for the treatment of androgenic alopecia, despite off-label use.
Beyond these two established treatments, cosmetic procedures such as scalp micropigmentation, scalp reduction or hair transplantation are becoming increasingly popular. “We continue to look forward to providing safe and effective stem cell therapy, which has promised much, while limited evidence on adjuvant therapies such as platelet-rich plasma (PRP) and low-level laser therapy (LLLT) has yet to prove convincingly,” he said. Wall, who is also an assistant professor at the Charles Institute of Dermatology at University College Dublin.
New treatments are forthcoming, but not in the near future
According to GlobalData’s Pharma Intelligence Center, there are currently 20 assets under development for androgenic alopecia. This ranges from minoxidil, which is in the process of pre-registration in Taiwan, to IVL3001, a one-month injection of finasteride by the South Korean company Inventage Lab, and treatments not previously used in space, such as a topical solution of Cosmo Pharmaceuticals Breezula (clascosterone).
Other approaches include antiandrogens such as GT-20029 or KX-826 (pyrilutamide), developed by the Chinese pharmaceutical company Kintor Pharmaceuticals. Pyrilutamide is currently in two phase II studies, one for men with androgenic alopecia in the United States and the other for women in China.
At the same time, Proudman emphasizes the need for efficient products, not those with promises. In June 2021, the Swedish company Follicum announcements discontinuation of phase IIa hair loss treatment FOL-005 after independent review has led to revised data that do not show significant improvement.
In that sense, Proudman says the upcoming treatments are likely to be similar to those in the existing arsenal.
“Even with the emergence of new therapies, it remains likely that optimal, sustained responses will require combination therapy, which should be chosen based on individual factors,” says Wall.
Note: This article has been updated to properly reflect the year in which minoxidil was approved for women.