The United Kingdom’s National Institute for Health and Care Excellence (NICE) last month recommended Zinbryta (daclizumab) to treat relapsing-remitting multiple sclerosis (RRMS) in England and Wales. On April 10, Scotland received Scottish Medicines Consortium (SMC) approval for the National Health Service (NHS) to prescribe Zinbryta as a treatment for RRMS.
Zinbryta is a disease-modifying drug that modulates the effects caused by the body’s immune system response, which are thought to drive the central nervous system symptoms observed in MS patients. Self-injection of Zinbryta once a month has shown promising results by reducing the occurrence of relapses and MS disability progression.
The drug, licensed by the European Medicines Agency (EMA) in July 2016, offers a treatment option for patients who require high-efficacy therapies or who have contra-indications to other treatments.
Results from the Phase 3 DECIDE (NCT01064401) and Phase 2b SELECT (NCT00390221) clinical trials have confirmed Zinbryta’s effectiveness and safety, and showed it to be more efficient than beta interferon treatments. This new modifying drug reduced the number of relapses by about 50 percent, while standard therapy with beta interferon reduced relapses b 45 percent in RRMS patients.
After NICE’s approval of Zinbryta, the SMC has now recommended Zinbryta prescriptions for those who have rapidly evolving severe RRMS, or for RRMS patients who do not respond to other disease modifying therapies.
“This is excellent news,” Pam Macfarlane, CEO of the MS Trust, said in a press release. “The approval of Zinbryta in Scotland expands the range of disease-modifying drugs by offering a different dosing schedule, a different mode of action and a different profile of benefits and risks compared to existing disease-modifying drugs.”
Still, previous clinical trials have reported adverse side effects linked to Zinbryta treatment; patients should consider these before beginning treatment. The most common of these are infections or swelling of the chest, nose and throat, increased levels of liver enzymes, skin rash or eczema, depression and swollen lymph glands.
More severe treatment adverse effects, including serious skin reactions and liver damage, are less common but were reported during clinical trials.