Associated tags: Itch, Ageing, Woman, Health, Prurigo nodularis, Clinical Trials, Pharmaceutical industry, Pharmaceutical, Biotechnology, III, Patient, Dermatology, Nemolizumab, Science, Research, Galderma, Congress, Managed Care, Skin, Other Health, Prurigo, Safety
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Pharmaceutical industry Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.
Key Points:
- Galderma today announced new data demonstrating nemolizumab’s long-term and increasing efficacy on skin lesions and other symptoms in prurigo nodularis through to week 52 in the OLYMPIA LTE study.1 Additionally, data from the ARCADIA 1 and 2 trials in atopic dermatitis indicate that the majority of patients maintained skin and itch responses through to week 48, with similar efficacy observed whether receiving nemolizumab every four (Q4W) or eight weeks (Q8W).2 These late-breaking data are being presented today at the 2024 American Academy of Dermatology Association (AAD) Annual Meeting, taking place on March 8-12, 2024.
build and strengthen for these debilitating diseases, where symptoms
such as intense itch can put a significant burden on quality of life.
- response in prurigo nodularis and atopic dermatitis, respectively.”
69% of those who had received continuous nemolizumab treatment and 65% of nemolizumab-naïve patients had reached clearance or almost-clearance of skin lesions, as measured on the Investigator’s Global Assessment (IGA) score
Sleep disturbance, as measured by the sleep disturbance numerical rating scale (SD-NRS), also continued to improve, as well as quality of life, as measured by the Dermatology Life Quality Index (DLQI).1
Results also reinforced nemolizumab’s rapid onset of action, with nemolizumab-naïve patients rapidly achieving an at least four-point improvement in itch intensity, as measured by the PP-NRS, as early as week four, consistent with the continuous-nemolizumab cohort.
- Nemolizumab was also granted U.S. FDA Priority Review for prurigo nodularis.
- Further submissions to regulatory authorities in additional countries are planned in 2024.
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Safety Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN).
Key Points:
- Incyte (Nasdaq:INCY) today announced results from a Phase 2 study evaluating the efficacy and safety of povorcitinib (INCB54707), an oral JAK1 inhibitor, in adult patients with prurigo nodularis (PN).
- Median times to itch NRS4 were 58, 35 and 17 days for patients who received 15, 45 and 75 mg of povorcitinib, respectively, and was not estimable for the placebo arm.
- We are excited to be expanding research on povorcitinib into this new potential indication.”
The secondary endpoints of the study were also met.
- The most common treatment-emergent adverse events (TEAEs) among patients who received povorcitinib were headache (11.1%), fatigue (9.3%) and nasopharyngitis (7.4%).
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Wednesday, February 14, 2024
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Priority review This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.
Key Points:
- This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.
- Priority Review is granted for medicines that would significantly improve the treatment, diagnosis or prevention of serious conditions.
- The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis.
- “The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life.
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Thursday, October 26, 2023
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Medicine Galderma today announced that the New England Journal of Medicine has published full results from the phase III OLYMPIA 2 trial evaluating the efficacy and safety of nemolizumab monotherapy in adults with prurigo nodularis.
Key Points:
- Galderma today announced that the New England Journal of Medicine has published full results from the phase III OLYMPIA 2 trial evaluating the efficacy and safety of nemolizumab monotherapy in adults with prurigo nodularis.
- Nemolizumab was well tolerated, and its safety profile was consistent with phase II trial results.1
This press release features multimedia.
- Results from the phase III OLYMPIA 2 trial will be submitted to selected health authorities around the world.
- To learn more about prurigo nodularis, watch this video from the New England Journal of Medicine.
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Wednesday, October 11, 2023
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Venereology Galderma announced positive data from three pivotal phase III trials in atopic dermatitis and prurigo nodularis – ARCADIA 1 and 2 and OLYMPIA 1, respectively.
Key Points:
- Galderma announced positive data from three pivotal phase III trials in atopic dermatitis and prurigo nodularis – ARCADIA 1 and 2 and OLYMPIA 1, respectively.
- The late-breaking data were presented today at the 2023 European Academy of Dermatology and Venereology (EADV) congress in Berlin.
- View the full release here: https://www.businesswire.com/news/home/20231011848851/en/
“While atopic dermatitis and prurigo nodularis are distinct diseases, their commonality lies in the severe, persistent itch, which leads to poor quality sleep and negatively impacts mental health.
- Statistically significant results at week 16 and earlier time points also show nemolizumab’s rapid onset of action on itch and sleep disturbance.
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Dermatology Galderma presented the latest data from its pivotal phase III OLYMPIA 2 trial at the 25th World Congress of Dermatology (WCD) in Singapore.
Key Points:
- Galderma presented the latest data from its pivotal phase III OLYMPIA 2 trial at the 25th World Congress of Dermatology (WCD) in Singapore.
- The study met all primary and secondary endpoints, demonstrating that nemolizumab monotherapy significantly improved itch, skin clearance and sleep disturbance.
- The safety profile was consistent with the phase II results.3
Galderma also presented the results of two Galderma-sponsored studies on the significant impact of prurigo nodularis and itch on sleep disturbance at WCD.
- These data demonstrate once again the massive burden those with prurigo nodularis face, and the extent of nemolizumab’s potential to address it.”
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Dermatology Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.
Key Points:
- Galderma has an extensive presence at the meeting with further updates from its broad portfolio across Therapeutic Dermatology, Dermatological Skincare and Injectable Aesthetics.
- The phase III OLYMPIA 2 trial met all primary endpoints, showing nemolizumab monotherapy significantly improved pruritus (itch) and skin lesions compared with placebo in adult patients with moderate to severe prurigo nodularis.
- “We are so pleased that we’re able to bring so much powerful new data to this year’s AAD congress.
- Its continued commitment to delivering science and innovation across a highly differentiated portfolio is reflected in its extensive presence at AAD.
