Merck Serono has informed the TGA of their decision to withdraw their product Movectro from supply. Movectro is the tradename of cladribine, approved in Australia in September 2010 for the treatment of relapsing-remitting multiple sclerosis (MS).
Merck Serono have indicated that additional clinical trials would be needed to meet US Food and Drug Administration and European Medicines Agency requirements for approval of Movectro. The company has decided not to pursue further the worldwide approval process for Movectro, based on the length of time it would take to complete these trials and the changing competitive landscape. The company, therefore, is discontinuing the supply of Movectro in Australia.
The TGA's approval of Movectro was based on the assessment that, under carefully controlled circumstances, the potential benefits to patients with MS outweighed the known risks associated with this product. A TGA-approved Risk Management Plan (RMP) is in place to ensure these risks are closely monitored and managed.
Movectro is currently only supplied in Australia through a limited number of neurologists, who participate in a program designed to ensure that the product is used in accordance with risk minimisation strategies outlined in the RMP. Side effects are strictly monitored and reported to the TGA.
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It is estimated that approximately 150 patients are currently prescribed Movectro in Australia. Treatment is only permitted for a maximum of two years.
The TGA will work with the sponsor and treating neurologists to ensure that patients who are receiving Movectro continue to receive appropriate ongoing care. Patients with concerns about their treatment with Movectro should contact their treating doctor.
Information on the evaluation process underpinning approval for Movectro is available at:
|AusPAR: Cladrabine Tablets (pdf)||2MB|