Efficacy

Efficacy of Ponvory (ponesimod) in Multiple Sclerosis

Ponvory (ponesimod) is a selective sphingosine-1-phosphate receptor modulator approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Clinical trials have demonstrated the efficacy of Ponvory in reducing the annualized relapse rate (ARR) in patients with MS. In a pivotal phase 3 trial, Ponvory significantly reduced ARR compared to another MS medication, teriflunomide, showcasing its potential in controlling disease activity.

Additionally, Ponvory has been shown to impact magnetic resonance imaging (MRI) markers of disease activity. In clinical studies, patients treated with Ponvory exhibited fewer new or enlarging T2 lesions and fewer gadolinium-enhancing lesions on MRI scans. These findings suggest that Ponvory can effectively reduce the inflammatory activity associated with MS, which is critical for managing the disease and slowing its progression.

Efficacy of Tyruko (natalizumab-sztn) in Multiple Sclerosis

Tyruko (natalizumab-sztn) is a biosimilar to the original natalizumab product and is indicated for the treatment of relapsing forms of multiple sclerosis (MS). Natalizumab, the active substance in Tyruko, is a monoclonal antibody that binds to the alpha-4 subunit of integrins expressed on the surface of leukocytes. This mechanism of action helps prevent leukocytes from migrating into the central nervous system (CNS), where they can cause inflammation and damage associated with MS. Clinical trials of the reference product have shown that natalizumab effectively reduces the annualized relapse rate and the progression of disability in patients with relapsing MS.

While Tyruko is a relatively new entrant in the MS treatment landscape, its efficacy is expected to be similar to that of the reference product, given that biosimilars must demonstrate no clinically meaningful differences in terms of safety, purity, and potency compared to the original biologic. The approval of biosimilars like Tyruko provides additional treatment options for patients with MS and may offer cost advantages that improve access to treatment. However, specific clinical data on Tyruko's efficacy in MS would be referenced from studies conducted on the reference product, natalizumab, until direct comparative studies are available.