FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne

Cassiopea SpA (SIX: SKIN),  announced   the United States Food and Drug Administration (FDA) approval of  Winlevi (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Notwithstanding acne being the most prevalent skin condition in the U.S. affecting up to 50 million Americans annually1, the last FDA approval of an acne drug with a new mechanism of action (MOA) occurred nearly 40 years ago.

Acne is a multifactorial skin condition, affected by four distinct pathways: excess oil (sebum) production, clogged pores (hyperkeratinization), bacteria growth (C. acnes), and inflammation2. Topical treatment options that target androgens, which largely drive sebum production and inflammation, presented a significant unmet need in the acne treatment market until now.

“The approval of Winlevi is an exciting breakthrough in acne treatment. This game-changing topical drug offers a non-antibiotic approach to people with acne, by targeting the androgen receptors directly in the skin. It fills a longstanding gap in acne therapy.” said Michael Gold, M.D., Investigator and Medical Director, Gold Skin Care Center and Tennessee Clinical Research Center. “After 40 years, it provides a much-anticipated, complementary new approach to treat acne.”

Cassiopea’s first-in-class topical androgen receptor inhibitor, Winlevi, tackles the androgen hormone component of acne in both males and females. Androgen receptor inhibitors act by limiting the effects of these hormones on increasing sebum production and inflammation3.

In pivotal clinical trials, Winlevi demonstrated treatment success and reductions in acne lesions and was well tolerated when used twice a day. The most frequently observed local skin reaction was mild erythema4,5.

Diana Harbort, CEO of Cassiopea, said: “This milestone approval marks the introduction of a new class of topical medication in Dermatology. Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females. We are proud to bring this new innovation to acne patients. This approval rewards many years of hard work and positions Cassiopea as a leader in Dermatology. Now we look forward to expanding our franchise and advancing our next investigational drug candidate for androgenetic alopecia.”

Winlevi is expected to be available in the United States in early 2021. Complete prescribing information is available on www.WINLEVI.com.

About Winlevi (clascoterone cream 1%)

Winlevi (clascoterone cream 1%) is approved for the treatment of acne vulgaris in people aged 12 and older. Although Winlevi’s exact mechanism of action is unknown, laboratory studies suggest the active ingredient, clascoterone, competes with androgens, specifically dihydrotestosterone (DHT), for binding to the androgen receptors within the sebaceous gland and hair follicles6.

https://en.wikipedia.org/wiki/Clascoterone

FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne

FDA Approves Aklief (trifarotene) Cream, a New Topical Retinoid for the Treatment of Acne

Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved Aklief (trifarotene) Cream, 0.005% for the topical treatment of acne. Aklief Cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.1,2,3 Trifarotene is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.4,5,6 Aklief Cream is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne, offering healthcare professionals and acne patients another treatment option.

"While retinoids are foundational therapies to treat acne, there has been little innovation in decades.” said Sandra Johnson, M.D., FAAD, an investigator in the clinical trials of Aklief Cream and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas. “With the approval of Aklief Cream, I am excited to offer my patients a unique, highly targeted retinoid that reduces inflammatory lesions on the face, back, chest and shoulders, that has also been shown to be safe and well-tolerated."

The FDA approval of Aklief Cream is supported by data from the two pivotal Phase 3 clinical trials of once-daily Aklief Cream in patients with moderate acne on the face and trunk.1 The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that Aklief Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05).1 Aklief Cream was well tolerated when used on the face, back, shoulders and chest.1 The most common adverse reactions (incidence >1%) included application site irritation, application site pruritus (itching) and sunburn.1 

“The approval of Aklief Cream underscores our ability to bring new active molecules to the community, and innovate even in well-established therapeutic classes. It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne,” said Thibaud Portal PhD, Galderma Global Vice President, Prescription. “We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments.”

Aklief Cream is expected to be available in the United States in November 2019. It will be provided in a 45 gram pump. Galderma is working closely with payers, providers and pharmacy benefit managers to ensure broad and rapid access to Aklief Cream. The company will also offer a patient savings card program, Galderma CareConnect*.

*Galderma CareConnect is only available for commercially insured or uninsured patients. Patients who are enrolled in a government-run or government-sponsored healthcare plan with a pharmacy benefit are not eligible to use the Galderma CareConnect Patient Savings Card.

 https://en.wikipedia.org/wiki/Trifarotene

Ortho Dermatologics Receives FDA Approval for Altreno (tretinoin 0.05%) Lotion For Acne

Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Altreno is the first formulation of tretinoin in a lotion, and has been shown to be effective and generally well-tolerated. Altreno is expected to be available during the fourth quarter of 2018.

FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user's experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen," said Bill Humphries, president, Ortho Dermatologics. "Altreno lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen."

Extensive clinical data has shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness and peeling, and sensitivity. In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients.1,2

"Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation," said Joshua Zeichner, M.D., director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital, New York City. "With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients."

Ref : https://www.drugs.com/history/altreno.html

FDA approves Cipher’s Absorica to treat severe recalcitrant nodular acne

FDA approves Cipher’s Absorica to treat severe recalcitrant nodular acne: Cipher Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Absorica, Cipher's novel, patented brand formulation of the acne medication isotretinoin (left structure), for the treatment of severe recalcitrant nodular acne.