AbbVie has announced that the European Commission (EC) has approved MAVIRET (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged three years and older.
The approval makes MAVIRET the only treatment in the European Union approved for both acute and chronic HCV infection.
Commenting on the approval, Roopal Thakkar, executive vice president, research and development, and chief scientific officer at AbbVie, said more than 12 million people in Europe are living with hepatitis C, highlighting the importance of earlier access to treatment.
He believes that the approval will enable earlier intervention, improve access to curative therapy at the time of diagnosis and support efforts to eliminate hepatitis C as a public health threat.
HCV is a highly infectious blood-borne disease that often goes undetected due to the absence of symptoms in many patients. Although curable, untreated infection can lead to serious liver complications, including cirrhosis and end-stage liver disease. Globally, HCV is associated with more than 200,000 deaths annually from liver cancer.
“People living with HCV infection frequently face delayed treatment, leading to loss to care and onward transmission,” said Massimo Puoti, director of the Infectious Diseases Department at Niguarda Hospital in Milan, Italy.
He noted that the approval provides healthcare professionals across the EU with an option to intervene earlier and potentially reduce disease progression and long-term complications.
MAVIRET is a once-daily, ribavirin-free, oral direct-acting antiviral therapy combining glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor.
The treatment is also approved in several countries, including the United States, Saudi Arabia, New Zealand, Canada, Taiwan, Australia, and Argentina, for treating acute and chronic HCV infection in adults and children aged three years and older.
Separately, the EC has approved SKYRIZI (risankizumab) for children and adolescents aged six years and older with moderate to severe plaque psoriasis who are eligible for systemic therapy.
The approval includes a new 55 mg pre-filled syringe designed to support weight-based dosing for patients weighing less than 40 kg.
Thakkar described the approval of SKYRIZI for pediatric psoriasis patients as “a meaningful step forward for millions worldwide who are looking for additional treatment options to better manage this chronic disease in their formative years.”
Psoriasis affects many children at an early age, with nearly one-third of patients developing symptoms before turning 18. The early onset of psoriasis can increase the risk of school absenteeism, potential social stigma, and the development of other comorbidities.Despite the significant impact of the disease on children’s quality of life, nearly 70 percent of pediatric patients rely solely on topical therapies.
SKYRIZI is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is linked to chronic immune-mediated diseases. It has been approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis in adults.
The EC approval of SKYRIZI in pediatric patients was based on data from the Phase 3 OptIMMize-1 paediatric psoriasis programme and the OptIMMize-2 extension study. In paediatric patients treated with SKYRIZI, the safety profile was consistent with that observed in adults and no new safety concerns were identified.
“Particularly for pediatric psoriasis patients, early diagnosis and management can prevent symptoms from worsening and improve quality of life in the long-term,” said Nina Magnolo, lead investigator of the OptIMMize-1 study.
“The EC’s approval of risankizumab provides younger patients with more options, including weight-based dosing and allows physicians to address unmet clinical needs of children living with moderate to severe psoriasis with confidence,” she added.
