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Cladribine (Mavenclad) licensed in US for active secondary progressive MS

Last week, the US Food and Drug Administration (FDA) approved cladribine as a treatment for adults with relapsing forms of MS, including active secondary progressive MS.

What does this mean?

The FDA is the body responsible for approving medicines in the USA. It's often the first national authority that global drug companies will submit marketing authorisations to.

This new license has been made based on reviewed evidence of the safety of the drug but not about its effectiveness at slowing or stopping disease progression.

This means at the moment it's unlikely the drug company will seek a European license to treat people with active secondary progressive MS.

If you're using cladribine to help manage your MS you won't be affected by this decision.

I’m living with secondary progressive MS, have my treatment options changed?

If you're living in the UK, your treatment options remain the same. Right now your neurologist can offer you limited treatments. We hope that will change soon.

When will treatment options for secondary progressive MS be available in the UK?

Since 1999, the NHS can only prescribe treatments that the National Institute for Care Excellence (NICE) approve for use. This is based on clinical results and value for money.

NICE usually only appraise drugs considered safe and effective by the European Medicines Agency (EMA). So we're still a way off from seeing cladribine being prescribed to people living with active secondary progressive MS in the UK.

We're also not sure of its effectiveness for people with secondary progressive MS.

Who can currently get cladribine in the UK?

When NICE appraised cladribine for the treatment of MS in 2017 they recommended it as an option for treating ‘highly active’ MS in adults.

Find out more about who can receive cladribine