Tysabri returns with new safety precautions
pharmafile | July 13, 2006 | News story | Sales and Marketing |Â Â Â
Multiple sclerosis drug Tysabri is set to be re-launched after overcoming serious concerns about its safety.
Co-marketed by Elan and Biogen Idec, Tysabri was first launched in the US in March 2005, but was withdrawn within weeks after several patients suffered a rare, but potentially fatal, infection as a result of taking the drug.
The drug was withdrawn voluntarily when three patients developed progressive multifocal leukoencephalopathy (PML), a brain infection that is often fatal.
The drug never reached the European market during 2005, but has now gained EU marketing approval and will be available to patients with special safety measures in place to prevent further cases of PML.
At its initial launch, Tysabri (natalizumab) was heralded as a major step forward in the treatment of MS and was forecast to earn more than $1 billion in peak sales.
Trials suggest the drug is significantly more effective than existing treatments in preventing relapse in patients, with the rate of clinical relapses being reduced by 66% compared to placebo and, when combined with the existing MS drug Avonex (interferon-beta), producing a 54% reduction in relapses compared to Avonex (the older drug) alone.
A labelling and risk management plan has been agreed in Europe, giving Tysabri marketing approval as a treatment for relapsing, remitting MS to delay the progression of disability and reduce the frequency of relapse.
To monitor the drug's future performance, a programme called TOUCH (Tysabri Outreach: Unified Commitment to Health) has been developed in conjunction with the FDA to ensure the appropriate use of the drug and to assess the risk and incidence of PML.
Elements of the prescribing programme agreed by the EC and the FDA include:
* Revised labelling, with a prominent warning of the risk of PML
* Warnings against the concurrent use of Tysabri with chronic immunosuppressant or immunomodulatory therapies
* A 5,000 patient cohort observational study over five years (the Tysabri Global Observation Programme in Safety TYGRIS), comprising 2,000 European and 3,000 US patients
* Ongoing assessment of PML risk and overall safety
The European decision comes in the wake of a fast-track review of the drug by the FDA, which has granted manufacturers a new licence to treat relapsing forms of MS even though two key studies are ongoing.
James Mullen, chief executive officer of Biogen, said: "This decision marks an important step forward for the European MS patient community. Tysabri represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice."
The FDA's decision to re-introduce the drug in the US, following a unanimous recommendation by the federation's peripheral and central nervous system drugs advisory committee to allow the introduction of Tysabri, was also welcomed.
Kelly Martin, chief executive of Elan, said: "We are pleased with the FDA's decision to, once again, make Tysabri available to patients and their families suffering from this chronic and debilitating disease.
"There continues to be a significant, unmet need where Tysabri will be an important treatment option."
