Merck KGaA said Friday that it plans to file for European approval of its experimental drug cladribine as a treatment for relapsing multiple sclerosis. The company noted that it has submitted a letter of intent to the European Medicines Agency to submit a marketing application, triggering the process to address a number of pre-submission requirements.
In 2011, Merck announced that based on feedback from regulators it would no longer pursue global marketing applications for cladribine, while it also withdrew the oral therapy from markets in Australia and Russia where it was previously approved under the name Movectro. The drugmaker said the latest decision follows the "evaluation of new data and additional analyses of the compound's benefit-risk profile."
"Time has brought additional data that allow a better characterisation of the benefit-risk profile of cladribine, and this has driven our decision to move forward with the registration process," explained Belén Garijo, CEO of healthcare at Merck. The company added that submission plans for other markets are "being further developed and executed."
For further analysis, read ViewPoints: Is there life left in Merck KGaA's cladribine?
Oral drugs already on the market to treat multiple sclerosis include Biogen's Tecfidera (dimethyl fumarate), which generated sales of $2.9 billion last year, Novartis' Gilenya (fingolimod), with annual revenue of $2.5 billion, and Sanofi's Aubagio (teriflunomide), which had full-year sales of 433 million euros ($488 million). For more information on the multiple sclerosis therapy area, see Multiple Sclerosis: KOL Insight.
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