https://www.fiercebiotech.com/biote...al-alopecia-phase-3-setting-up-showdown-lilly
Aug 4, 2021 8:50am
Pfizer's ritlecitinib hits goal in alopecia phase 3, setting up showdown with Lilly
by Nick Paul Taylor|Aug 4, 2021 8:50am
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Got hair loss? Big pharmas coming to your rescue
- Thread starter ginfreely
- Start date
Pfizer's alopecia therapy has been linked to a reduction in hair loss in early topline clinical data, setting the stage for a scrap with Eli Lilly and Incyte in the title fight for a potential blockbuster opportunity.
Ritlecitinib has met its primary endpoint in a phase 2b/3 clinical trial of patients with alopecia areata, Pfizer reported Wednesday. The update on the JAK3/TEC inhibitor comes months after Eli Lilly and Incyte reported late-phase success in alopecia.
There are currently no FDA-approved treatments for alopecia, an autoimmune disease characterized by hair loss, but multiple drugs could come to market in the indication over the coming years. Pfizer’s ritlecitinib joined Lilly and Incyte’s Olumiant on the list of drugs to hit the primary endpoint in pivotal alopecia trials on Wednesday—and Concert Pharmaceuticals is following closely behind.
Ritlecitinib has met its primary endpoint in a phase 2b/3 clinical trial of patients with alopecia areata, Pfizer reported Wednesday. The update on the JAK3/TEC inhibitor comes months after Eli Lilly and Incyte reported late-phase success in alopecia.
There are currently no FDA-approved treatments for alopecia, an autoimmune disease characterized by hair loss, but multiple drugs could come to market in the indication over the coming years. Pfizer’s ritlecitinib joined Lilly and Incyte’s Olumiant on the list of drugs to hit the primary endpoint in pivotal alopecia trials on Wednesday—and Concert Pharmaceuticals is following closely behind.
Pfizer is yet to share numbers from the phase 2b/3, but the top-line overview is positive. The clinical trial randomized 719 people who had at least 50% scalp hair loss at baseline to receive placebo or one of three doses of ritlecitinib, with or without a high-dose induction period.
The trial linked the two higher ritlecitinib doses to statistically significant increases in the proportion of patients who had 20% or less scalp hair loss at 24 weeks. Pfizer said the third, lower dose was used for dose ranging and not tested for statistically significant efficacy compared to placebo.
Lilly and Incyte also looked at the proportion of patients with 20% or less scalp hair loss and plan to file for approval in the second half of the year. Around one-third of patients on Olumiant had 20% or less scalp hair loss at week 36, compared with just a few percent of their peers on placebo. Pfizer is yet to share the data needed to compare ritlecitinib to Olumiant in terms of efficacy.
Safety could be a key battleground, too. In other indications, Olumiant carries a black box warning for infections, malignancies and thromboses. Pfizer saw eight cases of mild to moderate shingles, one case of pulmonary embolism and two malignancies in patients who received ritlecitinib. There were no major adverse cardiac events, deaths or opportunistic infections in the study.
The trial linked the two higher ritlecitinib doses to statistically significant increases in the proportion of patients who had 20% or less scalp hair loss at 24 weeks. Pfizer said the third, lower dose was used for dose ranging and not tested for statistically significant efficacy compared to placebo.
Lilly and Incyte also looked at the proportion of patients with 20% or less scalp hair loss and plan to file for approval in the second half of the year. Around one-third of patients on Olumiant had 20% or less scalp hair loss at week 36, compared with just a few percent of their peers on placebo. Pfizer is yet to share the data needed to compare ritlecitinib to Olumiant in terms of efficacy.
Safety could be a key battleground, too. In other indications, Olumiant carries a black box warning for infections, malignancies and thromboses. Pfizer saw eight cases of mild to moderate shingles, one case of pulmonary embolism and two malignancies in patients who received ritlecitinib. There were no major adverse cardiac events, deaths or opportunistic infections in the study.
Pfizer plans to combine the phase 2b/3 data with results from an ongoing long-term study to file for approval of ritlecitinib. The Big Pharma company has identified ritlecitinib as one of nine potential blockbusters it aims to launch by 2025.
As Pfizer sees it, ritlecitinib could rack up sales of more than $1 billion in alopecia alone. The drug is also in development in vitiligo, rheumatoid arthritis, ulcerative colitis and Crohn’s disease. Pfizer is up against more competitors in some of those indications but has been encouraged by midphase data generated to date.
As Pfizer sees it, ritlecitinib could rack up sales of more than $1 billion in alopecia alone. The drug is also in development in vitiligo, rheumatoid arthritis, ulcerative colitis and Crohn’s disease. Pfizer is up against more competitors in some of those indications but has been encouraged by midphase data generated to date.
Angmoh the best
Do all bald people have alopecia?
The vast majority of men who go bald do so because of a hereditary condition known as androgenetic alopecia, more commonly known as male pattern baldness. According to the American Hair Loss Association, 95 percent of hair loss in men is caused by androgenetic alopecia.
https://www.healthline.com/health/why-do-men-go-bald
The vast majority of men who go bald do so because of a hereditary condition known as androgenetic alopecia, more commonly known as male pattern baldness. According to the American Hair Loss Association, 95 percent of hair loss in men is caused by androgenetic alopecia.
https://www.healthline.com/health/why-do-men-go-bald
Alopecia areata
From Wikipedia, the free encyclopediaJump to navigationJump to search
| Alopecia areata | |
|---|---|
| Other names | Alopecia Celsi, vitiligo capitis, Jonston's alopecia[1] |
| |
| Alopecia areata seen on the back of the scalp | |
| Pronunciation |
|
| Specialty | Dermatology |
| Symptoms | Areas of hair loss, usually on the scalp[2] |
| Usual onset | Childhood[2] |
| Causes | Autoimmune[2] |
| Risk factors | Family history, rheumatoid arthritis, type 1 diabetes, celiac disease[2][3] |
| Differential diagnosis | Trichotillomania, alopecia mucinosa, postpartum alopecia[1] |
| Treatment | Sunscreen, head coverings to protect from sun and cold[2] |
| Medication | Cortisone injections[1] |
| Prognosis | Does not affect life expectancy[2][1] |
| Frequency | ~2% (US)[2] |
Alopecia areata is believed to be an autoimmune diseaseresulting from a breach in the immune privilege of the hair follicles.[4] Risk factors include a family history of the condition.[2] Among identical twins, if one is affected, the other has about a 50% chance of also being affected.[2]The underlying mechanism involves failure by the body to recognize its own cells, with subsequent immune-mediated destruction of the hair follicle.[2]
No cure for the condition is known.[2]
About one-third of women experience hair loss (alopecia) at some time in their lives; among postmenopausal women, as many as two-thirds suffer hair thinning or bald spots. Hair loss in women often has a greater impact than hair loss does on men w, because it's less socially acceptable for them.
Treating female pattern hair loss - Harvard Health
The main type of hair loss in women is the same as it is men. It's called androgenetic alopecia, or female (or male) pattern hair loss. In men, hair loss usually begins above the temples, and the receding hairline eventually forms a characteristic "M" shape; hair at the top of the head also thins, often progressing to baldness. In women, androgenetic alopecia begins with gradual thinning at the part line, followed by increasing diffuse hair loss radiating from the top of the head. A woman's hairline rarely recedes, and women rarely become bald.
There are many potential causes of hair loss in women , including medical conditions, medications, and physical or emotional stress. If you notice unusual hair loss of any kind, it's important to see your primary care provider or a dermatologist, to determine the cause and appropriate treatment. You may also want to ask your clinician for a referral to a therapist or support group to address emotional difficulties. Hair loss in women can be frustrating, but recent years have seen an increase in resources for coping with the problem.
Patterns of female hair loss
Clinicians use the Ludwig Classification to describe female pattern hair loss. Type I is minimal thinning that can be camouflaged with hair styling techniques. Type II is characterized by decreased volume and noticeable widening of the mid-line part. Type III describes diffuse thinning, with a see-through appearance on the top of the scalp. |
Almost every woman eventually develops some degree of female pattern hair loss. It can start any time after the onset of puberty, but women tend to first notice it around menopause, when hair loss typically increases. The risk rises with age, and it's higher for women with a history of hair loss on either side of the family.
As the name suggests, androgenetic alopecia involves the action of the hormones called androgens, which are essential for normal male sexual development and have other important functions in both sexes, including sex drive and regulation of hair growth. The condition may be inherited and involve several different genes. It can also result from an underlying endocrine condition, such as overproduction of androgen or an androgen-secreting tumor on the ovary, pituitary, or adrenal gland. In either case, the alopecia is likely related to increased androgen activity. But unlike androgenetic alopecia in men, in women the precise role of androgens is harder to determine. On the chance that an androgen-secreting tumor is involved, it's important to measure androgen levels in women with clear female pattern hair loss.
In either sex, hair loss from androgenetic alopecia occurs because of a genetically determined shortening of anagen, a hair's growing phase, and a lengthening of the time between the shedding of a hair and the start of a new anagen phase. (See "Life cycle of a hair.") That means it takes longer for hair to start growing back after it is shed in the course of the normal growth cycle. The hair follicle itself also changes, shrinking and producing a shorter, thinner hair shaft — a process called "follicular miniaturization." As a result, thicker, pigmented, longer-lived "terminal" hairs are replaced by shorter, thinner, non-pigmented hairs called "vellus."
As the name suggests, androgenetic alopecia involves the action of the hormones called androgens, which are essential for normal male sexual development and have other important functions in both sexes, including sex drive and regulation of hair growth. The condition may be inherited and involve several different genes. It can also result from an underlying endocrine condition, such as overproduction of androgen or an androgen-secreting tumor on the ovary, pituitary, or adrenal gland. In either case, the alopecia is likely related to increased androgen activity. But unlike androgenetic alopecia in men, in women the precise role of androgens is harder to determine. On the chance that an androgen-secreting tumor is involved, it's important to measure androgen levels in women with clear female pattern hair loss.
In either sex, hair loss from androgenetic alopecia occurs because of a genetically determined shortening of anagen, a hair's growing phase, and a lengthening of the time between the shedding of a hair and the start of a new anagen phase. (See "Life cycle of a hair.") That means it takes longer for hair to start growing back after it is shed in the course of the normal growth cycle. The hair follicle itself also changes, shrinking and producing a shorter, thinner hair shaft — a process called "follicular miniaturization." As a result, thicker, pigmented, longer-lived "terminal" hairs are replaced by shorter, thinner, non-pigmented hairs called "vellus."
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