Idea Description
Supplementary Information
Innovation 'Elevator Pitch':
Cladribine is a new oral therapy for the treatment of highly active Multiple Sclerosis (MS). It is effective in reducing relapses and can substantially reduce the administration and monitoring burden associated with other therapies currently in use.
Overview of Innovation:
The MS Society estimates that there are approximately 107,000 people with MS in the UK, and that each year 5,000 people are newly diagnosed with the condition. This means around one in every 600 people in the UK has MS. MS is between two to three times more common in women than men.

Multiple sclerosis is a chronic and debilitating autoimmune disorder of the central nervous system. In Multiple Sclerosis, the body’s own immune cells mistakenly attack the myelin that surrounds nerve fibres, leading to nerve damage.

Cladribine is a small oral molecule, developed by Merck, that selectively reduces the number and activity of these immune cells (B and T lymphocytes) and modulates cytokines. There is only a transient and relatively small effect on the innate immune cells such as neutrophils.

Cladribine Tablets have been investigated in 4 main phase II/III studies in MS. In a Phase III study (CLARITY), 3.5mg/kg Cladribine Tablets over 2 years (n = 433) with significantly reduced annualised relapse rates (ARR) by 77.8% in patients with Relapsing Remitting Multiple Sclerosis compared with placebo (n = 437) (p<0.001).

A phase IIIb extension study (CLARITY EXT) confirmed that the initial 2 year treatment with 3.5 mg/kg Cladribine Tablets was effective in reducing the frequency of relapses in years 3 and 4 by 75.6%.

A post hoc analysis of the CLARITY data, which focused on a subgroup with High Disease Activity, provided a consistent treatment effect on relapses for Cladribine Tablets compared with placebo.

The safety profile of Cladribine Tablets has been thorougly investigated in the 4 main phase II/III clinical studies and an ongoing PREMIERE registry.
Stage of Development:
Market ready and adopted - Fully proven, commercially deployable, market ready and already adopted in some areas (in a different region or sector)
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Oral cladribine for the treatment of highly active MS in adults has been designated as a 'rapid access ' technology by the Accelerated Access Collaborative

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