2019 news: FDA Approves Cladribine

[jimmylegs]

FDA Approves Cladribine -- Brand named Mavenclad® -- for People with Relapsing-Remitting MS and Active Secondary Progressive MS - UPDATE
https://www.nationalmssociety.org/About ... %C2%AE-for

March 29, 2019

UPDATED 4/2/19 with additional details and FAQs

SUMMARY
The U.S. Food and Drug Administration has approved oral cladribine (brand named Mavenclad®- EMD Serono) for the treatment of adults with relapsing forms of MS, including relapsing-remitting MS and active secondary progressive MS, based on clinical trials showing it could decrease the number of relapses and slow the accumulation of physical disability caused by MS, compared to placebo. Because of its safety profile, Mavenclad is generally recommended in people with MS who have had an inadequate response to, or are unable to tolerate, another MS therapy.
Mavenclad is a compound that targets certain types of white blood cells (lymphocytes) that drive the immune attack in MS. It temporarily reduces the number of both T and B lymphocytes without continuous suppression of the immune system.
Mavenclad has a boxed warning due to an increased risk of cancers and risk of fetal (unborn baby) harm.
Potential safety issues identified by the FDA include decrease in white blood cells, and increased risk of infections and liver injury. The most common adverse reactions reported during clinical trials included upper respiratory tract infections, headache, and low white blood counts.
Mavenclad is taken by mouth in two treatment courses, twelve months apart.
“This is an important breakthrough for people who do not respond to alternatives that have been approved to treat relapsing-remitting or active secondary progressive MS,” said Kathy Costello, MS, ANP-BC, MSCN, Associate Vice President of Healthcare Access at the National MS Society. “We are grateful that there is an additional option for people affected by these forms of MS.”

[jimmylegs]

Health Canada approves oral Mavenclad™ for the management of relapsing-remitting MS (2017)
https://mssociety.ca/research-news/arti ... mitting-ms

Mavenclad (cladribine) approved for use by the NHS in England and Wales (2017)
https://www.mstrust.org.uk/news/news-ab ... -and-wales

MAVENCLAD (CLADRIBINE) IS ADDED TO THE PHARMACEUTICAL BENEFITS SCHEME (2018) (Australia)
https://msra.org.au/news/mavenclad-clad ... ts-scheme/