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Monthly News Roundup - April 2019

Duobrii is a Unique Two-Ingredient Lotion Approved for Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) lotion, 0.01%/0.045%, from Bausch Health Companies Inc. has been cleared by the U.S. Food and Drug Administration (FDA) for use in the once-daily topical treatment of plaque psoriasis.

  • Duobrii contains a corticosteroid and retinoid combination. In two clinical studies, 36% and 45% of participants had achieved the primary efficacy outcome at week eight, compared to 7% and 13% using the vehicle.
  • Halobetasol and tazarotene are available generically as individual topicals, but in higher strengths.
  • Safety was demonstrated for up to 24 weeks with continuous use. The most common side effects are redness, itching, swelling, burning, and stinging, among others.
  • Duobrii Lotion is priced at $825 for a 100-gram tube, but insurance may cover costs. Duobrii is expected to be available in June 2019.

AbbVie’s IL-23 Inhibitor Skyrizi Approved for Plaque Psoriasis

The FDA has approved Skyrizi (risankizumab-rzaa) from AbbVie. Skyrizi is an interleukin-23 (IL-23) inhibitor biologic for the treatment of plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

  • The dose is a 150 mg subcutaneous (SQ) injection given every two weeks following an initial loading dose.
  • In study highlights, Skyrizi yielded a 90% skin clearance (PASI 90) in 75% of patients at 16 weeks compared to 5% and 2% receiving placebo. At one year, over 80% of participants receiving Skyrizi achieved 90% skin clearance, with the majority (56% and 60%) achieving complete skin clearance.
  • Common side effects include upper respiratory infections, headache, fatigue, injection site reactions and tinea (fungal) infections.

FDA OKs Janssen’s Balversa for Metastatic Bladder Cancer

In April the FDA granted accelerated approval for Janssen’s Balversa (erdafitinib), a once-daily oral treatment for adults with locally advanced or metastatic bladder cancer that has a fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alteration that has progressed during or following platinum-containing chemotherapy. Balversa is the first FGFR kinase inhibitor approved by the FDA.

  • In Phase 2 clinical trials, the overall response rate was 32.2%, with 2.3% having a complete response and 29.9% having a partial response. The response lasted a median of 5.4 months.
  • Patients who had not previously responded to anti PD-L1/PD-1 therapy responded to Balversa.
  • Common side effects include increased phosphate level, mouth sores, changes in kidney function tests, and diarrhea among others.

Amgen’s Evenity Cleared to Treat Women With High-Risk Osteoporosis

The FDA has approved Evenity (romosozumab-aqqg), a biologic anti-sclerostin monoclonal antibody used to treat osteoporosis in postmenopausal women at high risk of bone fracture.

  • In studies of more than 11,000 women with postmenopausal osteoporosis, Evenity lowered the risk of a new vertebral fracture by 73% compared to placebo at one year. This benefit was extended to 2 years when Evenity was followed by one year of denosumab (Prolia).
  • Evenity injection is given once a month by a healthcare professional but effectiveness wanes after 12 months. After 12 doses, patients should begin an osteoporosis treatment that reduces bone breakdown.
  • A Boxed Warning details the risk of serious heart effects. Adverse reactions may include joint pain, headache, and injection site reactions.

FDA Approves Dovato as the First Two-Drug Tablet for Untreated HIV

Lowering pill burden may promote treatment adherence in patients with HIV. The FDA has approved Dovato, which contains dolutegravir (Tivicay, DTG) and lamivudine (Epivir, 3TC), as a complete, once-daily, single-tablet regimen for the treatment of HIV-1 infection in adults who have never taken antiretroviral drugs.

  • Approval is based on two clinical trials of more than 1,400 HIV-infected adults with no prior antiretroviral treatment.
  • Dovato, from ViiV Healthcare, was similarly effective in reducing the amount of HIV in the blood as treatment with dolutegravir (Tivicay) plus emtricitabine + tenofovir disoproxil fumarate (Truvada).
  • The most common side effects are headache, diarrhea, nausea, insomnia, and fatigue.

Posted: April 2019