Novartis launches Ilaris in the UK
pharmafile | January 12, 2010 | News story | Sales and Marketing | Ilaris, Novartis, cryopyrin-associated periodic syndrome
Novartis has launched its new biologic Ilaris in the UK as a treatment for cryopyrin-associated periodic syndrome.
The rare debilitating auto-inflammatory disease affects around 2,500 people across the EU and Ilaris (canakinumab) is the first drug to win approval to treat affected patients aged four and above.
Novartis UK’s medical director Dr Tim Cave said: “We are excited to deliver a significant therapeutic advance for UK patients with this rare, debilitating and sometimes fatal disease.
“Novartis is committed to the development of innovative medicines for rare disorders. Canakinumab is the direct result of our pathways-driven search for novel medicines that are tailored to meet the needs of, and expand the treatment options for, patients with rare diseases.”
CAPS encompasses the auto-inflammatory disorders familial cold auto-inflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and neonatal-onset multi-system inflammatory disease (NOMID).
Symptoms, such as debilitating fatigue, fever, joint pain and conjunctivitis, can be present from infancy and continue throughout the patient’s life.
Currently Ilaris is the only treatment available in the UK to treat all three disorders and the only drug with European approval for NOMID, which is the most debilitating form of CAPS.
The UK launch follows an accelerated EU approval and priority reviews in the US and Switzerland where was also judged to be significant unmet medical need.
A monoclonal antibody, Ilaris is given by injection once every two months and works by selectively targeting and blocking interleukin-1 beta, the trigger for inflammation and tissue damage in CAPS patients.
Its approval was based on positive data showing Ilaris produces a remission of CAPS symptoms in up to 97% of patients, with most responding within 24 hours of the first injection.
The drug was approved in Switzerland in July 2009 to treat all three forms of CAPS in adults and children over four years old, and in the US in June 2009 to treat two forms of CAPS, namely FCAS and MWS, while a study in NOMID patients is under way.
Priority reviews are ongoing in other countries including Australia, Brazil and Canada.
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