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Year : 2020  |  Volume : 6  |  Issue : 2  |  Page : 101-102

News from regulatory corner: Safety communication and recent drug approvals

Kaya Skin Clinic, Bandra West, Mumbai, Maharashtra, India

Date of Submission15-Dec-2020
Date of Acceptance15-Dec-2020
Date of Web Publication28-Dec-2020

Correspondence Address:
Manasi Shirolikar
C-1, DAE Apts, 15th Road, Bandra West, Mumbai - 400 050, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijdd.ijdd_70_20

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How to cite this article:
Shirolikar M. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol 2020;6:101-2

How to cite this URL:
Shirolikar M. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol [serial online] 2020 [cited 2023 Jan 28];6:101-2. Available from: https://www.ijdd.in/text.asp?2020/6/2/101/305131


The following were the recently approved drugs for dermatology by the US Food and Drug Administration (USFDA) and/or European Commission.

1. Clascoterone 1% cream for the topical therapy of acne (Winlevi, Cassiopea)

The USFDA has approved clascoterone 1% cream for the topical therapy of acne, providing a treatment with a novel mechanism of action for acne.

Clascoterone is a topical androgen receptor inhibitor indicated for the treatment of acne vulgaris in patients aged 12 years and older, according to the labeling from manufacturer Cassiopea.

Although clascoterone's exact mechanism of action is unknown, laboratory studies suggest that clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles.

Approval was based in part on a pair of phase 3, double-blind, vehicle-controlled, 12-week, randomized trials including 1440 patients aged 9 years and older with moderate-to-severe facial acne.

At 12 weeks, treatment success rates were 18.4% and 20.3% among those on clascoterone, compared with 9% and 6.5%, respectively, among controls. There were also significant reductions in noninflammatory and inflammatory lesions from baseline at 12 weeks, compared with controls.

In the studies, treatment was well tolerated, with a safety profile similar to safety in controls. Adverse events thought to be related to clascoterone in the studies (a total of 13) included application-site pain; erythema; oropharyngeal pain; hypersensitivity, dryness, or hypertrichosis at the application site; eye irritation; headache; and hair color changes. Clascoterone targets androgen receptors at the site of application and is quickly metabolized to an inactive form, thus limiting systemic activity.

Clascoterone is expected to be available in the United States in early 2021, according to the manufacturer

Source: https://www.medscape.com/viewarticle/936427

2. Minocycline topical foam 1.5% for the treatment of inflammatory lesions of rosacea in adults (Zilxi, Menlo Therapeutics)

The USFDA approved the first minocycline product, minocycline topical foam 1.5% (Zilxi, Menlo Therapeutics) for use in rosacea.

The approval is based on in part on data from two randomized clinical trials involving 1522 adults with inflammatory lesions of rosacea who were assigned the minocycline topical foam or placebo once daily for 12 weeks. The co-primary efficacy end points were absolute change from baseline in inflammatory lesion counts at week 12, the proportion of participants with treatment success at week 12, defined as an Investor Global Assessment score of 0 (”clear”) or 1 (”almost clear”), and at least a two-grade decrease from baseline at week 12. Minocycline topical foam met both co-primary end points in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success. No treatment-related serious adverse events were reported.

The most common adverse reaction reported by <1% of participants was diarrhea.

Minocycline topical foam will likely be available by the fourth quarter of 2020, according to Menlo.

Source: https://www.healio.com/news/dermatology/20200529/fda-approves-topical-foam-for-rosacea-in-adults.

3. Approved drugs expanded to include children above 6 years

  • Dupixent (dupilumab) - Indication for moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable in children aged 6 years or older
  • Jublia (efinaconazole) - Indication for onychomycosis expanded to include children as young as 6 years
  • Taltz (ixekizumab) - Indication for plaque psoriasis expanded to include children aged 6 years or older
  • Eucrisa (crisaborole) ointment 2% - Indication for children as young as 3 months old with mild-to-moderate atopic dermatitis. It was previously approved for use in adults and children aged 2 years or older.

Source: https://reference.medscape.com/viewarticle/935244.

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Conflicts of interest

There are no conflicts of interest.


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