Polpharma Biologics gets FDA green light for multiple sclerosis treatment

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Fda Food and drug administration Multiple sclerosis Biosimilars

Polpharma Biologics, a biotech company developing and manufacturing biosimilars, has announced that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko.

Tyruko (natalizumab-sztn) is a new biosimilar for the treatment of relapsing forms of multiple sclerosis. The company said approval by the European Medicines Agency is also expected imminently.

Tyruko was developed by Polpharma Biologics and will be made available to patients in the U.S. by its collaboration partner Sandoz.

The treatment is approved as a monotherapy to treat all indications covered by reference medicine Tysabri (natalizumab) for relapsing forms of MS; including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease, and Crohn’s disease in adults.

Tyruko has the same intravenous (IV) dosage form, route of administration, dosing regimen and presentation as monoclonal antibody disease modifying treatment Tysabri.  

MS is a progressive, chronic inflammatory and neurodegenerative disease of the central nervous system that can take a heavy toll on the lives of those affected and requires lifelong treatment.

Broader access to more affordable treatment options is needed to reduce the substantial economic impact of MS to healthcare systems – per year, the disease costs the U.S. economy as much as $85.4 billion in the direct and indirect healthcare expenditure.

Polpharma Biologics retains responsibility for manufacturing and supplying Tyruko. Sandoz has the rights to commercialize and distribute the biosimilar under an exclusive global license.

Michael Soldan, CEO at Polpharma Biologics Group, said: “Targeted therapies are the cornerstone of care for people with MS, but high medication prices are fueling access issues and healthcare expenditure. The need to address the rising costs of this devastating disease to patients and societies inspired the scientific teams at Polpharma Biologics to develop an efficacious MS biosimilar. We are delighted that the FDA’s approval of Tyruko means clinicians will soon have access to an affordable treatment that can change the lives of people with relapsing MS. We will support our partner Sandoz to bring Tyruko to patients as quickly as possible.”

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