Basic Information
Tyruko
Regulatory Information
EMEA/H/C/005752
September 22, 2023
July 20, 2023
1
November 20, 2023
Company Information
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI.
Overview Summary
Tyruko is a medicine used in adults to treat highly active multiple sclerosis (MS) that is rapidly getting worse or that is not sufficiently controlled with at least one other disease-modifying therapy (a therapy that can modify the course of the disease). MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding nerves and damages the nerves themselves. Tyruko is used in relapsing-remitting MS, a type of MS in which the patient has attacks (relapses) between periods of stable symptoms (remissions). Tyruko is a ‘biosimilar medicine’. This means that Tyruko is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Tyruko is Tysabri. For more information on biosimilar medicines, see [here](/en/biosimilar-medicines-overview). Tyruko contains the active substance natalizumab.