The European Commission has approved Merck KGaA’s Mavenclad (cladribine tablets) to treat highly active relapsing forms of multiple sclerosis (MS). The Aug. 25 decision in Brussels marks the first approval of a highly efficient oral short course therapy for MS in Europe.
Mavenclad has been shown to harness disease activity for four years after a maximum of 20 treatment days over two years.
“Multiple sclerosis is one of the world’s most common neurological disorders,” Belén Garijo, CEO of Merck Healthcare and member of the company’s executive board, said in a press release. “With the approval of Mavenclad in the European Union, we are pleased to offer patients and clinicians an innovative agent with a simplified dosing schedule as a new approach to managing active relapsing MS.”
The approval, which allows Merck to market Mavenclad in the European Union’s 28 member countries plus Iceland, Liechtenstein and Norway, builds on data from more than 2,700 patients who participated in clinical trials. Some patients have been followed for up to 10 years.
Regulators got access to data from the Phase 3 clinical trials CLARITY (NCT00213135), CLARITY EXTENSION (NCT00641537), and ORACLE-MS (NCT00725985), as well as the Phase 2 ONWARD trial (NCT00436826), and the ongoing long-term study PREMIERE (NCT01013350).
In June, the European Medicines Agency’s Committee for Medicinal Products for Human Use urged the EC to approve Mavenclad, which had earlier been rejected by both European and U.S. health authorities because of concerns about an increased cancer risk.
These concerns have, however, have receded, and Merck has produced plenty of additional data supporting Mavenclad’s effectiveness in relapsing forms of MS. Independent researchers also found the treatment to improve patients’ quality of life.
“This is an exciting moment, and one that will change the way we treat MS,” said neurology professor Gavin Giovannoni of Barts and The London School of Medicine and Dentistry, Queen Mary University of London.
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