The oral dosage form of the Mavenclad (cladribine) treats adults with relapsing-remitting disease and active secondary progressive disease forms of multiple sclerosis (MS).
In 2011, the US Food and Drug Administration (FDA) rejected the treatment, asking the company to provide additional safety analysis.
The delay allowed rivals to steal a march by taking their treatments to market earlier, such as with Novartis Gilenya (fingolimod) and Roche’s Ocrevus (ocrelizumab), amongst others.
Despite the delay, Mavenclad provides a short-course, oral treatment dosing schedule, which differentiates the therapy from what is already on the market.
Patients taking the treatment are required to take five tablets in the first month and again in the second month of treatment, which is all that is required for the first year of treatment. This dosing is repeated for the second year, allowing Merck KGaA to state that 20 days of oral dosing provides two years of treatment.
Belén Garijo, CEO Healthcare of Merck KGaA, “We feel privileged to introduce Mavenclad into clinical practice in the US. Mavenclad opens a new way to treat MS – a treatment that requires a maximum of 20 days of oral therapy to deliver two years of efficacy to a patient.”
To receive its approval, Merck carried out a clinical trial program including 1,976 patients, with an average follow up period of close to five years.
However, the FDA’s previous safety concerns regarding the drug have been followed through with a boxed warning regarding an increased risk of cancer and foetal harm. Due to the latter factor, the agency has cautioned that the drug should not be used in pregnant women, or in men and women of ‘reproductive potential’ who do not plan to use effective contraception during treatment.