On 24 June 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fingolimod Mylan, intended for the treatment of relapsing-remitting multiple sclerosis with high disease activity.
The applicant for this medicinal product is Mylan Ireland Limited.
Fingolimod Mylan will be available as 0.5 mg hard capsules. The active substance of Fingolimod Mylan is fingolimod hydrochloride, a selective immunosuppressant (ATC code: L04AA27) acting as a sphingosine 1-phosphate (S1P) receptor modulator. Fingolimod hydrochloride is metabolised to the active metabolite fingolimod phosphate, which blocks the capacity of lymphocytes to egress from lymph nodes and reduces the infiltration of pathogenic lymphocyte cells into the central nervous system.
Fingolimod Mylan is a generic of Gilenya, which has been authorised in the EU since 17 March 2011. Studies have demonstrated the satisfactory quality of Fingolimod Mylan and its bioequivalence to the reference product Gilenya.
The full indication is:
Fingolimod Mylan is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:
- Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.
- Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Fingolimod Mylan should be prescribed by physicians experienced in the treatment of multiple sclerosis.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
|Agency product number||
|International non-proprietary name (INN) or common name||
Multiple Sclerosis, Relapsing-Remitting
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
|Date opinion adopted||