Kineret® approved in Canada for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Tuesday, May 30, 2017 Child Health News
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TORONTO, May 30, 2017 /CNW/ - Sobi Canada Inc., a subsidiary of Swedish Orphan Biovitrum AB (publ) (Sobi™), today

announces that Health Canada has approved Kineret® (anakinra) for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) in adults, adolescents, children and infants aged eight months and older with a body weight of 10 kg or above.
Kineret is already approved in Canada for active rheumatoid arthritis (RA) in patients 18 years of age or older.

"Without proper treatment, children and adults with NOMID may experience crippling inflammation in many body systems. The approval of Kineret for NOMID in Canada will provide both children and adults with an important treatment option," says Dr. Ron Laxer, academic physician and physician administrator at the Hospital for Sick Children and the University of Toronto.

"This approval means so much to the Canadian patients and families living with NOMID," says Durhane Wong-Rieger, president of the Canadian Organization for Rare Disorders. "We are grateful to Sobi for their commitment and all of their support to the patient community."

"This approval by Health Canada represents an important milestone in our efforts to make innovative therapies available to patients with debilitating and often life-threatening diseases," says Bob McLay, vice-president and general manager, Sobi Canada Inc.

Sobi will provide Kineret for home treatment in a prefilled syringe with a graduated label to allow precise and flexible dosing in children and adults. Kineret is also approved in the U.S. and Europe for the treatment of NOMID and RA, and is a proprietary product developed and made available globally by Sobi.

About NOMIDNeonatal-onset multisystem inflammatory disease (NOMID) is a rare autoinflammatory disease with an incidence estimated to be 1:1,000,000 worldwide, associated with chronic meningitis, hearing loss, craniofacial abnormalities, bone lesions and increased mortality.

About Kineret®Kineret® (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation and a significant contributor to autoinflammatory diseases. Kineret has a well-characterised safety profile, a quick onset of action and a short half-life.

About Sobi™Sobi is an international specialty healthcare company dedicated to rare diseases. Sobi's mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2016, Sobi had total revenues of SEK 5.2 billion (USD 608 M) and about 760 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More information is available at www.sobi.com.

SOURCE Sobi Canada Inc.



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