Sobi announced that the EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion for anakinra (Kineret) for the treatment of Still’s disease.
This morning, Swedish Orphan Biovitrum AB (Sobi) announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for anakinra (Kineret) for the treatment of Still’s disease.
The opinion is now referred to the European Commission (EC) for a final decision.
Anakinra is an interleukin-1 receptor antagonist. In the United States, it is indicated for reduction in signs and symptoms and delaying the progression of structural damage in moderately to severely active rheumatoid arthritis in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs. It is also indicated in the U.S. for the treatment of neonatal-onset multisystem inflammatory disease (NOMID),
In October, Sobi randomized the first patient in a Phase 3 study evaluating the safety and efficacy of the drug for the treatment of Still’s disease. The condition is an autoinflammatory disease, characterized by symptoms like spiking fever, typical transient cutaneous rash, arthritis, lymphadenopathy, hepatosplenomegaly, and serositis.
In the video below, Len Walt, the Vice President and Head of Medical Affairs at Sobi in North America explains the pathophysiology of Still’s disease, and also the mechanism of action and targets for anakinra.
"We are very pleased with the CHMP positive opinion which recommends including this indication for Kineret in the [European Union],” said Milan Zdravkovic, Chief Medical Officer and Head of Research and Development at Sobi in a press release. “Sobi is committed to improving the lives of people affected by rare diseases, and this recommendation, if approved by the European Commission, would help address an unmet medical need for people with Still's disease.”
The new proposed indication for Kineret reads:
"Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids.
Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs)."
In October, Rare Disease Report sat down with Rami Levin, President of Sobi in North America. In the video below, he discusses the challenges in working in the rare disease community, like the limited information available to patients, caregivers and family members, as well as the difficulties that come in the attempt to access treatment options.