Novartis obtains EU positive opinion for new biologic drug

Novartis obtains EU positive opinion for new biologic drug

Jul 28, 2009 -- Swiss pharmaceutical group Novartis has reported that the EU's Committee on Human Medicinal Products has issued a positive opinion recommending the approval of Ilaris for cryopyrin-associated periodic syndrome or CAPS, a fatal auto-inflammatory disease.

The recommendation comes shortly after approvals in the US and Switzerland where Ilaris was granted priority review based on its potential to fulfil an important unmet need for CAPS patients. When approved, Ilaris will be the only treatment in the EU indicated for CAPS patients aged four years and older.

The Committee on Human Medicinal Products recommended approval under exceptional circumstances, granted when comprehensive data are not yet available due to the rarity of the disease or limited scientific knowledge. The approval is subject to certain obligations for the company and is re-assessed each year until normal approval can be given.

The EU submission was supported by data showing that Ilaris, a monoclonal antibody formerly known as ACZ885, produced rapid and sustained remission of symptoms in up to 97% of CAPS patients, with most responding from the first injection.

Ilaris 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 familial cold auto-inflammatory syndrome and Muckle-Wells syndrome. A study in neonatal-onset multisystem inflammatory disease patients is underway in the US and priority reviews are being conducted in other countries, including Australia and Canada.

Trevor Mundel, head of global development at Novartis Pharma, said: "By concentrating initially on a rare syndrome with a well-defined disease process such as CAPS, we have been able to demonstrate a clear therapeutic advantage with Ilaris. Our focus now is to establish whether this could also provide a new approach to the treatment of other diseases involving a similar underlying process."


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