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Year : 2019  |  Volume : 5  |  Issue : 1  |  Page : 72-74

News from regulatory corner: Safety communication and recent drug approvals

Consultant Dermatologist, Bandra West, Mumbai, Maharashtra, India

Date of Web Publication22-Jul-2019

Correspondence Address:
Dr. Manasi Shirolikar
C-1, DAE (BARC) Building, 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_28_19

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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 2019;5:72-4

How to cite this URL:
Shirolikar M. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol [serial online] 2019 [cited 2023 Apr 1];5:72-4. Available from: https://www.ijdd.in/text.asp?2019/5/1/72/263094


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

  Risankizumab for Moderate-To-Severe Plaque Psoriasis (Skyrizi, Abbvie) Top

The European Commission has approved risankizumab (Skyrizi, AbbVie) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the drug 2 months ago.

Risankizumab is a humanized monoclonal antibody that targets the p19 subunit of interleukin (IL)-23, a cytokine involved in inflammatory and immune responses, therefore, inhibiting the release of pro-inflammatory cytokines involved in psoriasis disease.

The approval was granted on the basis of results from the four Phase 3 studies, involving >2000 patients with moderate-to-severe plaque psoriasis. There was a significantly higher response to risankizumab, in which patients experienced clear or almost clear skin (Static Physicians Global Assessment 0/1 and Psoriasis Area and Severity Index 90), compared to ustekinumab, adalimumab, and placebo at week 16 and up to week 52 (depending on study design), according to AbbVie. The company plans to present 2-year data from one of the studies at the World Congress of Dermatology in June 2019 at Milan, Italy.

The most common adverse reactions were upper respiratory infections, which occurred in 13% of patients. Most of the reported adverse reactions were of mild or moderate severity. Skyrizi will be available as a 75 mg solution for injection. It is to be administered in two initiation doses at week 0 and week 4, followed by two subcutaneous injections of 75 mg each every 12 weeks.


  1. https://www.medscape.com/viewarticle/909742
  2. https://www.medscape.com/viewarticle/912474
  3. https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-skyrizi_en.pdf.

  Calcipotriene Foam (0.005%) For Plaque Psoriasis (Sorilux, Mayne Pharma Group) Top

The USFDA has approved calcipotriene foam, 0.005% for the treatment of plaque psoriasis of the scalp and body in adolescents aged 12 years or older. Calcipotriene is a synthetic Vitamin D analog that has a similar receptor binding affinity as natural Vitamin D and regulates skin cell production and growth. The pharma group suggests the use of calcipotriene with lexette (halobetasol propionate) foam.

Foam delivery platform is claimed to have an ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing.

A thin layer of the foam should be applied twice daily to the affected areas and rubbed in gently and completely. The foam is for topical use only and is not for oral, ophthalmic, or intravaginal use. It should not be used by patients who have elevated blood calcium levels (hypercalcemia). The propellant in the foam is flammable, thus the patient must avoid fire, flame, and smoking during and immediately following application. Transient, rapidly reversible elevation of serum calcium has occurred with the use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Calcipotriene was approved by the USFDA in 2010 on the basis of results from two 8-week placebo-controlled clinical trials that included patients with mild-to-moderate plaque psoriasis of the body and one 8-week placebo-controlled study in patients with moderate plaque psoriasis of the scalp. Additional data were provided by a follow-on open-label trial in adolescents with psoriasis.


  1. https://www.medscape.com/viewarticle/913407
  2. https://www.prnewswire.com/news-releases/fda-approves-soriluxr-for-adolescent-plaque-psoriasis-300854930.html.

  Halobetasol Propionate And Tazarotene (0.01%/0.045%) Lotion For Treatment Of Plaque Psoriasis ( Duobrii , Bausch Health) Top

The USFDA has approved the first lotion containing halobetasol propionate and tazarotene (0.01%/0.045%) (Duobrii, Bausch Health) for treatment of adult plaque psoriasis.

In a Phase 2 study, the halobetasol propionate/tazarotene combination lotion was more effective than its individual agents and vehicle in achieving treatment success (defined as at least a two-grade improvement from baseline in an Investigator Global Assessment score, and “clear” or “almost clear” skin) and reducing signs of psoriasis such as erythema, plaque elevation, and scaling at the target lesion.

In a post hoc analysis of the data, in which the vehicle effect was removed, the efficacy of Duobrii was superior to the aggregated results of the individual agents.

The most common adverse events in clinical trials included redness, itching, swelling, burning, stinging, application site pain, folliculitis, atrophy, peeling, and rash.


  1. https://www.medscape.com/viewarticle/912299
  2. https://www.bauschhealth.com/news-room/news-releases/news-details/201904251317pr_news_uspr_____ny30972.

  Dupilumab For Adolescents With Poorly Controlled Moderate-To-Severe Atopic Dermatitis (Dupixent, Sanofi /Regeneron) Top

The USFDA has approved dupilumab (Dupixent, Sanofi/Regeneron) for adolescents aged 12–17 years with moderate-to-severe atopic dermatitis poorly controlled with topical prescription therapies or when those therapies are not advisable. In 2017, the FDA had approved dupilumab for adults with moderate-to-severe atopic dermatitis.

Dupilumab inhibits IL-4 and IL-13, which may play a central role in type 2 inflammation involved in atopic dermatitis and other allergic diseases.

In a Phase 3 trial evaluating dupilumab monotherapy in adolescents with uncontrolled moderate-to-severe atopic dermatitis, the safety and efficacy were generally consistent with those previously seen in studies involving adults. Average improvement from baseline in the Eczema Area and Severity Index (EASI) score was roughly 66% compared with 24% with placebo. Twenty-four percent of patients treated with dupilumab achieved clear or almost clear skin compared with just 2% of patients treated with placebo. Forty-two percent of patients achieved 75% (EASI-75) or greater skin improvement with dupilumab versus 8% with placebo, as measured by EASI. Thirty-seven percent of patients treated with dupilumab achieved a clinically meaningful improvement in itch of at least four points on the Peak Pruritus Numerical Rating Scale compared with 5% with placebo.

Dupilumab has been studied in >7000 patients aged 12 years or older in over 30 clinical trials, the company said. The safety profile in adolescents is similar to that in adults. Adverse effects include injection-site reactions, eye and eyelid inflammation including redness, swelling and itching, oropharyngeal pain, and cold sores in the mouth or on the lips. Dosage: Available as single-dose prefilled syringe – 300 mg/2 mL or 200 mg/1.14 mL ≥60 kg: 600 mg (i.e. two 300-mg injections) SC once, and then 300 mg SC every other week <60 kg: 400 mg (i.e., two 200-mg injections) SC once, and then 200 mg SC every other week can be used with or without topical corticosteroids.

Topical calcineurin inhibitors may be used but should be reserved for problem areas only (e.g. face, neck, intertriginous, and genital areas).

Source: https://www.medscape.com/viewarticle/910277.

  Omadacycline For Acute Skin And Skin Structure Infection ( Nuzyra , Paratek Pharmaceuticals) Top

The USFDA has approved omadacycline (Nuzyra, Paratek Pharmaceuticals) for treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infection (ABSSSI).

Omadacycline is a modernized tetracycline with broad-spectrum activity that is designed to overcome tetracycline resistance.

It is approved for ABSSSI caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus group(includes S. anginosus, Staphylococcus intermedius, and Streptococcus constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

In three global Phase 3 studies involving about 2000 adults, omadacycline met all the primary and secondary efficacy outcomes designated by the FDA and the European Medicines Agency and was generally safe and well tolerated, the company notes in a news release.

Omadacycline comes in intravenous (IV) and oral formulations. It is also the first and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSIs in nearly 20 years.

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline- or tetracycline-class antibacterial drugs. Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients >65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

The use of NUZYRA during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of NUZYRA during the second and third trimester of pregnancy, infancy, and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drug, and may occur with NUZYRA.

The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

Dosage: For IV dosage, a loading dose of 200 mg by IV infusion over 60 min or 100 mg by IV infusion over 30 min twice on the 1st day, followed by 100 mg by IV infusion over 30 min once daily or 300 mg orally once daily the following days.

For oral administration, a loading dose of 450 mg once on day 1 and day 2, followed by 300 mg once daily for 7-14 days.


  1. https://www.medscape.com/viewarticle/902885
  2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209816_209817lbl.pdf.

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Conflicts of interest

There are no conflicts of interest.


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