AbbVie’s SKYRIZI Approved by EU for Pediatric Psoriasis Treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 hours ago
0mins
Source: PRnewswire
- EU Approval: AbbVie announced that its drug SKYRIZI (risankizumab) has received approval from the European Commission for treating moderate to severe plaque psoriasis in children aged six and older, marking a significant advancement in pediatric dermatology.
- Dosing Innovation: The introduction of a new 55 mg pre-filled syringe (PFS) supports weight-based dosing specifically for patients weighing less than 40 kg, aiming to enhance treatment personalization and efficacy.
- Clinical Data Support: The approval is backed by clinical data from the Phase 3 OptIMMize-1 study involving 137 pediatric patients, demonstrating a safety profile consistent with adults and no new safety signals, thereby boosting physician confidence in the treatment.
- Social Impact: With nearly 70% of pediatric patients relying solely on topical therapies, the approval of SKYRIZI provides more treatment options for children, aiming to improve their quality of life and reduce risks of school absenteeism and social stigma associated with the disease.
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Analyst Views on ABBV
Wall Street analysts forecast ABBV stock price to rise
18 Analyst Rating
12 Buy
6 Hold
0 Sell
Moderate Buy
Current: 216.490
Low
223.00
Averages
252.00
High
289.00
Current: 216.490
Low
223.00
Averages
252.00
High
289.00
About ABBV
AbbVie Inc. is a global, diversified, research-based biopharmaceutical company. It is engaged in research and development, manufacturing, commercialization and sale of medicines and therapies. Its product portfolio includes Immunology, Oncology, Aesthetics, Neuroscience, Eye Care and Other Key Products. Immunology products include rheumatology, dermatology and gastroenterology. Oncology products include Imbruvica, Venclexta/Venclyxto, Elahere and Epkinly. The aesthetics portfolio consists of facial injectables, plastics and regenerative medicine, body contouring, and skincare products. Its Neuroscience products include Botox Therapeutic, Vraylar, Duopa and Duodopa, Ubrelvy, and Qulipta. Duodopa is a levodopa-carbidopa intestinal gel for the treatment of Parkinson's disease. Eye care products include Ozurdex, Lumigan/Ganfort, Alphagan/Combigan, Restasis, and other eye care. Other key products include Mavyret/Maviret, Creon, and Linzess/Constella.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
AbbVie’s SKYRIZI Approved by EU for Pediatric Psoriasis Treatment
- EU Approval: AbbVie announced that its drug SKYRIZI (risankizumab) has received approval from the European Commission for treating moderate to severe plaque psoriasis in children aged six and older, marking a significant advancement in pediatric dermatology.
- Dosing Innovation: The introduction of a new 55 mg pre-filled syringe (PFS) supports weight-based dosing specifically for patients weighing less than 40 kg, aiming to enhance treatment personalization and efficacy.
- Clinical Data Support: The approval is backed by clinical data from the Phase 3 OptIMMize-1 study involving 137 pediatric patients, demonstrating a safety profile consistent with adults and no new safety signals, thereby boosting physician confidence in the treatment.
- Social Impact: With nearly 70% of pediatric patients relying solely on topical therapies, the approval of SKYRIZI provides more treatment options for children, aiming to improve their quality of life and reduce risks of school absenteeism and social stigma associated with the disease.
See More
SKYRIZI® Approved for Pediatric Psoriasis Treatment
- New Indication Approval: AbbVie announced that SKYRIZI® (risankizumab) has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in children and adolescents aged six and older, marking a significant advancement in pediatric dermatology.
- Dosing Innovation: The approval includes a new 55 mg pre-filled syringe designed for patients weighing less than 40 kg, enhancing treatment personalization and efficacy, which is expected to improve the quality of life for pediatric patients.
- Clinical Data Support: This approval is backed by data from the Phase 3 OptIMMize-1 and OptIMMize-2 trials involving 137 pediatric patients, demonstrating a safety profile consistent with that of adults, with no new safety signals observed, thereby boosting physician confidence in the treatment.
- Social Impact: Given that nearly a third of psoriasis patients develop symptoms before age 18, the approval of SKYRIZI not only provides more treatment options for children but also has the potential to reduce school absenteeism and social stigma associated with the disease, highlighting its significant societal value.
See More
AbbVie’s MAVIRET Approved by EU for Acute HCV Treatment
- EU Approval: AbbVie's MAVIRET (glecaprevir/pibrentasvir) has received approval from the European Commission, becoming the only treatment for both acute and chronic HCV infections, solidifying the company's leadership in the global antiviral market.
- Market Demand: With over 12 million people living with HCV in Europe, the approval of MAVIRET enables more patients to access curative therapy at the time of diagnosis, accelerating efforts to eliminate HCV as a public health threat.
- Clinical Trial Success: In a Phase 3 clinical trial involving 286 patients, MAVIRET demonstrated a 96.2% sustained virological response rate, proving its efficacy in treating acute HCV infections and further strengthening its competitive position in the market.
- Good Safety Profile: The clinical trial reported that the majority of adverse events were mild to moderate, with fatigue, diarrhea, and headache being the most common, indicating a favorable safety profile that enhances physician confidence in prescribing the drug.
See More
MAVIRET® Approved in EU for Acute Hepatitis C Treatment
- Expanded Treatment Options: MAVIRET® (glecaprevir/pibrentasvir) has been approved in the EU for treating acute hepatitis C in adults and children aged 3 and older, allowing clinicians to initiate treatment immediately upon confirmation of acute infection, thereby reducing delays in care and lowering the risks of disease progression, cirrhosis, and liver cancer.
- Clinical Data Support: In a Phase 3 clinical trial involving 286 treatment-naïve patients with acute HCV infection, MAVIRET demonstrated a 96.2% sustained virological response (SVR12) at 12 weeks post-treatment, indicating its high efficacy in acute HCV cases, with no serious adverse reactions reported.
- Public Health Impact: With over 12 million people living with HCV in Europe, the approval of MAVIRET provides a potential for earlier intervention, aiming to help more individuals access curative therapy at the time of diagnosis, thus accelerating efforts to eliminate HCV as a public health threat.
- Global Collaboration: AbbVie continues to collaborate with global regulatory authorities to support the access of MAVIRET for patients with acute HCV infection, further advancing the global goal of HCV elimination and reinforcing its leadership in hepatitis C treatment.
See More
AbbVie’s Skyrizi Approved by EU for Pediatric Psoriasis Treatment
- Drug Approval: AbbVie announced that its drug Skyrizi (risankizumab) has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in children aged six and older, marking a significant advancement in pediatric dermatology.
- Clinical Trial Support: The approval is based on pivotal phase 3 trials, OptIMMize-1 and OptIMMize-2, demonstrating Skyrizi's efficacy in pediatric patients, thereby reinforcing its potential in systemic therapy applications.
- Dosing Innovation: The introduction of a new 55 mg pre-filled syringe specifically designed for patients weighing less than 40 kg allows for more precise dosing, addressing the unique needs of pediatric patients and enhancing treatment personalization.
- Safety Warnings: AbbVie cautions that risankizumab is contraindicated in patients with hypersensitivity to the active substance or excipients and should be used cautiously in patients with a history of chronic infections to mitigate infection risks and ensure patient safety.
See More
AbbVie’s SKYRIZI Approved for Pediatric Psoriasis in Europe
- Regulatory Milestone: AbbVie announced that its drug SKYRIZI has received European Commission approval for children and adolescents aged six and older with moderate to severe plaque psoriasis, marking a significant advancement in pediatric treatment and expected to significantly boost market demand and company revenue.
- Pediatric Patient Needs: Nearly one-third of psoriasis patients develop symptoms before age 18, and despite facing social stigma and health risks, about 70% of pediatric patients rely solely on topical therapies, highlighting the urgent need for systemic treatment options that SKYRIZI now addresses.
- Clinical Data Support: The approval of SKYRIZI is supported by data from the Phase 3 OptIMMize-1 and OptIMMize-2 clinical trials, demonstrating a safety profile in patients aged 6 to 17 consistent with adults, with no new safety signals identified, thereby enhancing physician confidence in the drug.
- Market Performance and Future Outlook: SKYRIZI generated $4.483 billion in global revenue in Q1 2026, up from $3.425 billion in Q1 2025, reflecting strong market demand, and AbbVie is also pursuing FDA approval for the drug in treating Crohn's disease, which is expected to further drive revenue growth.
See More
AbbVie’s SKYRIZI Approved by EU for Pediatric Psoriasis Treatment
- EU Approval: AbbVie announced that its drug SKYRIZI (risankizumab) has received approval from the European Commission for treating moderate to severe plaque psoriasis in children aged six and older, marking a significant advancement in pediatric dermatology.
- Dosing Innovation: The introduction of a new 55 mg pre-filled syringe (PFS) supports weight-based dosing specifically for patients weighing less than 40 kg, aiming to enhance treatment personalization and efficacy.
- Clinical Data Support: The approval is backed by clinical data from the Phase 3 OptIMMize-1 study involving 137 pediatric patients, demonstrating a safety profile consistent with adults and no new safety signals, thereby boosting physician confidence in the treatment.
- Social Impact: With nearly 70% of pediatric patients relying solely on topical therapies, the approval of SKYRIZI provides more treatment options for children, aiming to improve their quality of life and reduce risks of school absenteeism and social stigma associated with the disease.
See More
SKYRIZI® Approved for Pediatric Psoriasis Treatment
- New Indication Approval: AbbVie announced that SKYRIZI® (risankizumab) has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in children and adolescents aged six and older, marking a significant advancement in pediatric dermatology.
- Dosing Innovation: The approval includes a new 55 mg pre-filled syringe designed for patients weighing less than 40 kg, enhancing treatment personalization and efficacy, which is expected to improve the quality of life for pediatric patients.
- Clinical Data Support: This approval is backed by data from the Phase 3 OptIMMize-1 and OptIMMize-2 trials involving 137 pediatric patients, demonstrating a safety profile consistent with that of adults, with no new safety signals observed, thereby boosting physician confidence in the treatment.
- Social Impact: Given that nearly a third of psoriasis patients develop symptoms before age 18, the approval of SKYRIZI not only provides more treatment options for children but also has the potential to reduce school absenteeism and social stigma associated with the disease, highlighting its significant societal value.
See More
AbbVie’s MAVIRET Approved by EU for Acute HCV Treatment
- EU Approval: AbbVie's MAVIRET (glecaprevir/pibrentasvir) has received approval from the European Commission, becoming the only treatment for both acute and chronic HCV infections, solidifying the company's leadership in the global antiviral market.
- Market Demand: With over 12 million people living with HCV in Europe, the approval of MAVIRET enables more patients to access curative therapy at the time of diagnosis, accelerating efforts to eliminate HCV as a public health threat.
- Clinical Trial Success: In a Phase 3 clinical trial involving 286 patients, MAVIRET demonstrated a 96.2% sustained virological response rate, proving its efficacy in treating acute HCV infections and further strengthening its competitive position in the market.
- Good Safety Profile: The clinical trial reported that the majority of adverse events were mild to moderate, with fatigue, diarrhea, and headache being the most common, indicating a favorable safety profile that enhances physician confidence in prescribing the drug.
See More
MAVIRET® Approved in EU for Acute Hepatitis C Treatment
- Expanded Treatment Options: MAVIRET® (glecaprevir/pibrentasvir) has been approved in the EU for treating acute hepatitis C in adults and children aged 3 and older, allowing clinicians to initiate treatment immediately upon confirmation of acute infection, thereby reducing delays in care and lowering the risks of disease progression, cirrhosis, and liver cancer.
- Clinical Data Support: In a Phase 3 clinical trial involving 286 treatment-naïve patients with acute HCV infection, MAVIRET demonstrated a 96.2% sustained virological response (SVR12) at 12 weeks post-treatment, indicating its high efficacy in acute HCV cases, with no serious adverse reactions reported.
- Public Health Impact: With over 12 million people living with HCV in Europe, the approval of MAVIRET provides a potential for earlier intervention, aiming to help more individuals access curative therapy at the time of diagnosis, thus accelerating efforts to eliminate HCV as a public health threat.
- Global Collaboration: AbbVie continues to collaborate with global regulatory authorities to support the access of MAVIRET for patients with acute HCV infection, further advancing the global goal of HCV elimination and reinforcing its leadership in hepatitis C treatment.
See More
AbbVie’s Skyrizi Approved by EU for Pediatric Psoriasis Treatment
- Drug Approval: AbbVie announced that its drug Skyrizi (risankizumab) has been approved by the European Commission for the treatment of moderate to severe plaque psoriasis in children aged six and older, marking a significant advancement in pediatric dermatology.
- Clinical Trial Support: The approval is based on pivotal phase 3 trials, OptIMMize-1 and OptIMMize-2, demonstrating Skyrizi's efficacy in pediatric patients, thereby reinforcing its potential in systemic therapy applications.
- Dosing Innovation: The introduction of a new 55 mg pre-filled syringe specifically designed for patients weighing less than 40 kg allows for more precise dosing, addressing the unique needs of pediatric patients and enhancing treatment personalization.
- Safety Warnings: AbbVie cautions that risankizumab is contraindicated in patients with hypersensitivity to the active substance or excipients and should be used cautiously in patients with a history of chronic infections to mitigate infection risks and ensure patient safety.
See More
AbbVie’s SKYRIZI Approved for Pediatric Psoriasis in Europe
- Regulatory Milestone: AbbVie announced that its drug SKYRIZI has received European Commission approval for children and adolescents aged six and older with moderate to severe plaque psoriasis, marking a significant advancement in pediatric treatment and expected to significantly boost market demand and company revenue.
- Pediatric Patient Needs: Nearly one-third of psoriasis patients develop symptoms before age 18, and despite facing social stigma and health risks, about 70% of pediatric patients rely solely on topical therapies, highlighting the urgent need for systemic treatment options that SKYRIZI now addresses.
- Clinical Data Support: The approval of SKYRIZI is supported by data from the Phase 3 OptIMMize-1 and OptIMMize-2 clinical trials, demonstrating a safety profile in patients aged 6 to 17 consistent with adults, with no new safety signals identified, thereby enhancing physician confidence in the drug.
- Market Performance and Future Outlook: SKYRIZI generated $4.483 billion in global revenue in Q1 2026, up from $3.425 billion in Q1 2025, reflecting strong market demand, and AbbVie is also pursuing FDA approval for the drug in treating Crohn's disease, which is expected to further drive revenue growth.
See More
