This new delivery route involves a subcutaneous injection in which Tysabri is injected under the skin. Compared with the previously approved intravenous (into the bloodstream) formulation, this one can be given in less time, in settings beyond infusion centers, and requires no or shorter post-observation periods after the first six doses.
It also offers patients undergoing Tysabri treatment another option, enabling them to choose the one that best fits their needs, according to the therapy’s manufacturer, Biogen.
Regardless of the administration method, Tysabri is given at a dose of 300 mg every four weeks.
“The subcutaneous administration of Tysabri expands choices when it comes to controlling MS disease activity,” Sven G. Meuth, MD, PhD, said in a press release. Meuth is a professor of neurology and director of the Clinic of Neurology at the University Hospital of Düsseldorf in Germany.
“I believe the SC [subcutaneous] administration offers an opportunity to receive comparable efficacy and safety to the intravenous formulation with reduced administration time which may be meaningful for patients. For physicians, the SC administration offers the ability to prescribe and administer Tysabri in their practice, providing more locations where patients can be treated,” Meuth said.
Tysabri is an antibody therapy that works by stopping immune cells from entering the brain and spinal cord, where they could cause damage to myelin — the fatty coating on nerve fibers — and contribute to MS progression.
The therapy was approved in Europe in 2006 for the treatment of RRMS. In the U.S., Tysabri is used for relapsing forms of MS, which, in addition to RRMS, include clinically isolated syndrome and active secondary progressive MS.
The EC’s recent approval comes on the heels of data from the clinical trials DELIVER (NCT00559702) and REFINE (NCT01405820), which compared the subcutaneous and intravenous forms of Tysabri in about 350 people with RRMS and SPMS.
These data showed that the effectiveness of the two routes was similar, as were the pharmacokinetic and pharmacodynamic profiles — that is, how the medication moves through the body and how it affects the body.
The safety profiles of the two routes also were similar, although it was noted that injection site pain may occur with the subcutaneous route. Common side effects of Tysabri include headaches, nausea, urinary tract infections, depression, and joint pain. The medication also may increase the risk of progressive multifocal leukoencephalopathy (PML), a rare type of brain infection.
“Tysabri is a trusted high-efficacy therapy with a well characterized safety profile for patients living with MS. Nearly 15 years of real-world experience helps reinforce its effectiveness in reducing MS disease activity, showing that early treatment leads to better clinical outcomes,” said Maha Radhakrishnan, MD, Biogen’s chief medical officer.
“With chronic conditions like MS, we must continue to pursue innovations that can help patients better integrate their treatment preferences into their lives,” Radhakrishnan said. “This approval reflects our commitment to explore new possibilities with Tysabri and meet the evolving needs of people living with MS.”
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