Three new drugs for the treatment of multiple sclerosis under evaluation at INFARMED

February 25, 2015 | By Márcio Barra


According to a report by Diário Digital, three new drugs to treat multiple sclerosis are awaiting reimbursement approval from INFARMED ( the portuguese national competent authority) and shall be made available to portuguese patients later this year.

In a statement from Dr.  Maria José de Sá, coordinator of the Demyelinating Diseases Clinic of the São João Hospital, patients will soon have access to “two oral drugs in tablet formulation ‘to replace intramuscular or subcutaneous auto-injectable drugs. The two oral drugs are Fampyr (fampridine), and Tecfidera (dimethyl fumarate).

Fampyr was approved last year by INFARMED, for the Improvement of walking in patients with Multiple Sclerosis. The cost of the monthly treatment (1 tablet BID) is 177.15 euros, with a full 100% reimbursement. The drug´s approval by the European Medicines Agency was in 2011.

Tecfidera is indicated for relapsing-remitting Multiple Sclerosis, and the drug was quite a hit when it launched in the US in 2013. The drug became the most-prescribed pill, easily beating its oral competition shortly after launch – Sanofi’s Aubagio (teriflunomide) and Novartis’ Gilenya (fingolimod) – reaching 13% of market share on its own compared with their combined 12.3%. Tecfidera is currently one of the main drivers of growth for Biogen Idec.

The drug´s success lies in its safety profile. Aubagio carries the risk of liver injury and birth defects, while Gilenya, although first to reach the market, has been held back by heart safety concerns. Tecfidera side effects include a decrease in a person’s white blood cell count, alongside nausea, vomiting, and diarrhea, which tended to get better over time without stopping the drug. The drug was also cheaper when it launched in the US than Gilenya, but was more expensive than Aubagio. Both Fampyr and Tecfidera are commercialized by Biogen Idec, and they are currently undergoing cost effectiveness analysis by INFARMED.

The third drug is an injectable monoclonal antibody, called Lemtrada (Alemtuzumab), from Genzyme, for the treatment of relapsing-remitting multiple sclerosis. Owing to its status as a biologic drug, the drug will have a higher cost and administration will occur solely on an hospital setting. The drug´s use is reserved for very severe cases. Lemtrada was approved by the European Commission in 2013, and the drug has a unique dosing and administration schedule consisting of 2 annual treatment courses. The first course is given as an intravenous infusion over 5 consecutive days, and the second over 3 days 12 months later.

This coming Friday and Saturday (February 27 – 28) is the Third International Porto Congress of Multiple Sclerosis, held in the Demyelinating Diseases Clinic of the São João Hospital. Innovative treatments are one of the issues highlighted for discussion, alongside pediatric multiple sclerosis and the costs of the disease in Europe.

  1. escharae said:

    Tecfidera was supposed to be approved in 2014 and it wasn’t.
    Fampyra was approved in August 2014 but it still isn’t available in most hospitals.
    Meanwhile, I’ve been waiting for the past four months to switch from Copaxone to Tysabri, which has been in use for the past years.
    So this news is only relatively good news, as the drugs being approved doesn’t mean they will become available to patients in time.

    • Hello escharae, thank you for your insightful comment!

      Yes, unfortunately, the approval of these drugs is something that is being delayed time and time again. I am only somewhat familiar with the struggles that Multiple Sclerosis patients face (I have worked as a clinical trial coordinator in neurology, including multiple sclerosis), and the burden of the disease is incredibly high. I wish you the very best, and I hope that Tecfidera is soon brought to Portuguese patients.

      Again, thank you for comment.

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