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    Susquehanna Raises Penn Entertainment Inc. (PENN) Price Target. – Yahoo Finance

    Susquehanna Raises Price Target for Penn Entertainment Inc. (PENN)

    George Lopez is coming to Spokane – KXLY.com

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    Susquehanna Raises Penn Entertainment Inc. (PENN) Price Target. – Yahoo Finance

    Susquehanna Raises Price Target for Penn Entertainment Inc. (PENN)

    George Lopez is coming to Spokane – KXLY.com

    George Lopez is coming to Spokane – KXLY.com

    Netflix unveils Dallas immersive venue for fans of hit shows like ‘Squid Game,’ ‘Stranger Things’ – Houston Chronicle

    Step Inside Netflix’s New Dallas Immersive Experience Featuring Hits Like ‘Squid Game’ and ‘Stranger Things

    ‘Puttin’ on the Ritz’: Civic Players bring ‘Young Frankenstein’ to life – Yahoo

    Civic Players Deliver a Hilarious and Unforgettable Performance of ‘Young Frankenstein

    ‘Wheel of Fortune’: Amputee Wins $60,000 After Breaking Incredible ‘Curse’ – Hastings Tribune

    Wheel of Fortune’ Amputee Breaks Incredible ‘Curse’ to Win $60,000!

    North Star Sports & Entertainment Network: Coming soon – KTTC News

    North Star Sports & Entertainment Network: Coming soon – KTTC News

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    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

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    PAP Boss to Niger Delta Youths, Stay Away from the Protest

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    Court Restricts Protests In Lagos To Freedom, Peace Park

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    Defense technology giant Northrop Grumman to host interviews in Iuka to fill technician roles – supertalk.fm

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FDA Approves Topical Eczema Rx for Ages 6 or Older

July 11, 2024
in Health
FDA Approves Topical Eczema Rx for Ages 6 or Older
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On July 9, the US Food and Drug Administration approved the supplemental new drug application for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and in pediatric patients aged 6 years or older.

Roflumilast cream 0.15%, which has been developed by Arcutis Biotherapeutics and is marketed under the brand name Zoryve, is a steroid-free topical phosphodiesterase 4 inhibitor that was previously approved in a higher concentration to treat seborrheic dermatitis and plaque psoriasis.

According to a press release from Arcutis, approval for AD was supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials. In two identical phase 3 studies known as INTEGUMENT-1 and INTEGUMENT-2, about 40% of children and adults treated with roflumilast cream 0.15% achieved a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5% vs 25.2%; P <.0001 integument-2: vs p with significant improvement as early week>

Among children and adults who participated in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% achieved an Eczema Area and Severity Index-75, respectively. According to the company, there were no adverse reactions in the combined phase 3 pivotal trials that occurred in more than 2.9% of participants in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The product is expected to be available commercially at the end of July 2024, according to Arcutis. Roflumilast cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 6 years or older; roflumilast foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients aged 9 years or older. 

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : Medscape – https://www.medscape.com/viewarticle/roflumilast-cream-approved-eczema-patients-2024a1000cpx

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