2023-08-15 10:20:31
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the biosimilar version of the disease-modifying treatment natalizumab (TMM) for adults with highly active relapsing-remitting multiple sclerosis (RRMS).
Nearly 1.2 million people are reached multiple sclerosis (MS) in Europe. In 2018, 43% of those affected were not receiving MDA, mainly due to high treatment costs and a lack of access.
The main challenge in MS treatment today is choosing from an increasing number of MMTs in a way that balances efficacy, safety and cost of treatment, while providing personalized treatment. This is explained by Melinda Magyari, director of the Danish Multiple Sclerosis Registry and neurology consultant at Rigshospitalet Hospital in Copenhagen. She was not involved in the drug development or approval process.
L’economic impact Estimates of MS on healthcare systems can be high and reach €37,000 to €57,000 per patient per year in direct and indirect costs for people with moderate to severe disease.
The reference version of natalizumab is a humanized monoclonal antibody directed once morest α4-integrins and authorized for the treatment of RRMS. “Natalizumab is one of the most effective MMTs and has an important place in the treatment algorithm for John Cunningham virus-negative patients,” Magyari told Univadis.com. “Therefore, a less expensive alternative with similar efficacy, safety and immunogenicity might benefit patients and allow them to start [à utiliser] very effective drugs at the very beginning of the disease,” she added.
Natalizumab, which has just received a favorable opinion from the CHMP, is a biosimilar medicine: “a biological product very similar to an already approved medicine”, explains Mr. Magyari. “It is designed to have the same safety and efficacy profile as the reference medicine and is intended to be used for the same indication. »
The positive CHMP opinion is supported by evidence from a phase I pharmacokinetic/pharmacodynamic study and a confirmatory phase III study, ANTELOPE, involving 264 patients with RRMS who were randomly assigned to receive the biosimilar version of natalizumab or the reference biologic intravenously every 4 weeks for 48 weeks. The primary efficacy analysis revealed comparable efficacy for the cumulative number of unique active lesions combined (AUC) between the biosimilar and its reference. At week 24, the point estimate of the difference in the cumulative number of AUC lesions (0.17; -0.613 to 0.944) was well within the predefined margins (±2.1).
The safety profiles were comparable: no cases of progressive multifocal leukoencephalopathy or death were observed in either group.
Magyari believes that some aspects of MS therapy still lag behind and need attention and improvement. These include developing treatments for progressive and late-stage MS and for repairing nerve damage, as well as finding better drugs to reduce relapses and the development of new lesions on MRIs. .
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