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Year : 2018  |  Volume : 4  |  Issue : 2  |  Page : 97-98

News from regulatory corner: Safety communication and recent drug approvals

Consultant Dermatologist, Bandra West, Mumbai, Maharashtra, India

Date of Web Publication31-Dec-2018

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: 10.4103/2455-3972.249190

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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 2018;4:97-8

How to cite this URL:
Shirolikar M. News from regulatory corner: Safety communication and recent drug approvals. Indian J Drugs Dermatol [serial online] 2018 [cited 2020 Oct 30];4:97-8. Available from: https://www.ijdd.in/text.asp?2018/4/2/97/249190


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

  1. Sarecycline for moderate-to-severe acne (Seysara, Almirall): The USFDA has approved a new tetracycline-derived oral antibiotic, sarecycline, for patients aged >9 years with nonnodular moderate-to-severe acne vulgaris. Sarecycline is contraindicated in those with hypersensitivity to any tetracyclines and can induce permanent tooth discoloration if used during tooth development. The most frequently seen side effect is nausea (≥1%); however, it has also been associated with central nervous system adverse effects, including lightheadedness, dizziness, and vertigo. Almirall recently
  2. Acquired sarecycline for the United States as a part of Allergan's Medical Dermatology portfolio and is expected to be available in January 2019. Dosage forms and strengths (tablet) – 60, 100, and 150 mg. <54 kg: 60 mg; 55–84 kg: 100 mg; and 85–136 kg: 150 mg. Can be taken with or without food. If improvement after 12 weeks was not observed, reevaluate the treatment. Source: https://www.medscape.com/viewarticle/902826
  3. First tretinoin lotion for acne (Altreno, Ortho Dermatologics): The USFDA has approved tretinoin 0.05% lotion for the treatment of acne vulgaris in patients aged ≥9 years. Altreno lotion was a generally well-tolerated formulation, providing the efficacy of tretinoin with skin dryness, pain, swelling, irritation, and peeling reported in ≤4% of patients according to the company release. The lotion was assessed in two Phase 3, double-blind, vehicle-controlled clinical trials of a total of 1640 patients aged ≥9 years. In both studies, Altreno lotion caused statistically significant reductions in both inflammatory and noninflammatory lesions compared with vehicle. The most frequent adverse reactions in >1% of participants and greater than with control vehicle were dryness, pain erythema, irritation, and exfoliation. Sunscreen and protective clothing should be worn when sun exposure cannot be averted. As there is a possibility for allergenicity to fish protein, Altreno should be used vigilantly in patients who are allergic to fish. A thin layer of Altreno is to be applied to affected areas once daily, avoiding eyes, mouth, paranasal creases, and mucous membranes. Each gram of lotion contains 0.5-mg (0.05%) tretinoin. Source: https://www.medscape.com/viewarticle/901240
  4. Topical glycopyrronium for primary axillary hyperhidrosis (Qbrexza, Dermira): The USFDA has approved topical glycopyrronium cloth for the treatment of primary axillary hyperhidrosis in patients aged ≥9 years. The anticholinergic action inhibits sweat gland activation, thereby blocking the sweat production. With Qbrexza, patients experienced a “noticeable and sustained reduction in their overall sweat production,” the company said in a news release announcing FDA approval. The most common adverse reactions, seen in at least 2% of patients treated with Qbrexza, were due to its anticholinergic nature such as dry mouth (24.2%), mydriasis, oropharyngeal pain, headache, urinary hesitation, blurred vision, nasal dryness, dry throat, dry eye, dry skin, and constipation. Local skin reactions, including erythema (17.0%), burning/stinging, and pruritus, were also common. Qbrexza is contraindicated in patients with medical conditions such as glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, and Sjögren's syndrome that can be aggravated by anticholinergics. Restraint must be exercised in patients with a history or currently having urinary retention. Qbrexza is to be applied once daily to both axillae using a single cloth which is premoistened with 2.4% glycopyrronium solution. Source: https://www.medscape.com/viewarticle/898719
  5. Tofacitinib for active psoriatic arthritis (Xeljanz/Xeljanz XR, Pfizer): The USFDA has approved tofacitinib for the treatment of adults with active psoriatic arthritis (PsA) who have failed to respond adequately or are intolerant to methotrexate (MTX) or other disease-modifying antirheumatic drugs (DMARDs). Tofacitinib is a selective oral Janus kinase inhibitor, which works by interrupting the signaling of several cytokines involved in immune response. It was first approved by the FDA in 2012 for adults with moderate-to-severe active rheumatoid arthritis (RA) who have not responded adequately to, or are intolerant of, MTX. The safety profile of tofacitinib observed in patients with PsA was consistent with the safety profile observed in RA patients. The most common side effects (>3% of patients) were nasopharyngitis, upper respiratory tract infection, headache, and diarrhea. Patients getting the drug are at greater risk of serious infections leading to hospitalization or death. Most patients who developed these infections were also taking other immunosuppressants such as MTX or corticosteroids. If a serious infection develops, tofacitinib should be withheld until the infection has subsided. It is available as oral tablets (Xeljanz) and extended-release tablets (Xeljanz XR). In combination with nonbiologic DMARDs – Xeljanz 5 mg twice daily or Xeljanz XR 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Xeljanz 5 mg once daily. The use of tofacitinib in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. The use of Xeljanz/Xeljanz XR in patients with severe hepatic impairment is not recommended in any patient population. Xeljanz/Xeljanz XR is not to be initiated if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count <1000 cells/mm3, or hemoglobin <9 g/dL. Source: https://www.medscape.com/viewarticle/890255
  6. Ixekizumab to treat adults with active psoriatic arthritis (Taltz, Eli Lilly): The USFDA has approved ixekizumab to treat adults with active PsA. Ixekizumab is a humanized monoclonal antibody that targets interleukin 17A, which advances inflammation in psoriasis. Ixekizumab is administered as an injection either alone or in combination with a conventional DMARD, such as MTX. Ixekizumab was first approved in the United States in March 2016 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ixekizumab is contraindicated in patients with a previous serious hypersensitivity reaction to the drug or to any of the excipients. Ixekizumab may increase the risk for infection. Other warnings and precautions include pretreatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease, and immunizations. For plaque psoriasis, it is administered by subcutaneous injection. The recommended dose is 160 mg (two 80 mg injections) at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. For PsA, the recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, followed by 80 mg every 4 weeks. For PsA patients with coexistent moderate-to-severe plaque psoriasis, use the dosing regimen for plaque psoriasis. Taltz may be administered alone or in combination with a conventional DMARD (e.g., MTX). Source: https://www.medscape.com/viewarticle/889714
  7. Cemiplimab for metastatic cutaneous squamous cell carcinoma (Libtayo, Regeneron Pharmaceuticals): The USFDA approved cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC), or locally advanced, unresectable CSCC. It is the first FDA approval specifically for advanced CSCC. Cemiplimab is an immunotherapy agent that targets the PD-1 pathway and thus may help the body's immune system fight the cancerous cells. This is the sixth different immune checkpoint inhibitor targeting the PD-1/PD-L1 pathway approved by the FDA for treating various tumors, which now includes CSCC. Common side effects include fatigue, rash, and diarrhea. The drug can cause severe or life-threatening reactions such as pneumonitis, colitis, hepatitis, and endocrinopathies as well as dermatologic and kidney problems. Patients should also be watched for infusion-related reactions. Only a small percentage of CSCC patients, the FDA said, will develop advanced disease that no longer responds to local treatments including surgery and radiation and thus are candidates for cemiplimab.

It is available as an injectable solution of 350 mg/7 mL (50 mg/mL) single-dose vial. It is to be given as 350 mg IV q 3 weeks infused over 30 min till disease progression or unacceptable toxicity. Source: https://www.medscape.com/viewarticle/902729.

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