Patient safety is our highest priority, and we are committed to disclosing the benefits and risks of our therapies to help healthcare professionals and patients make informed treatment choices.
This commitment includes providing up-to-date safety information in product labeling directed to healthcare professionals and patients. In addition, Biogen Idec may provide information about the safety of our therapies through other communications, such as letters to healthcare professionals, as appropriate. We also review all our promotional materials to ensure that they include accurate information on products’ risks and benefits.
We collect information on an ongoing basis regarding adverse reactions from physicians who prescribe and patients who use our therapies. Additionally, in some instances, we conduct post-marketing studies to evaluate therapies’ long-term effects.
We take safety issues seriously. When a safety issue or adverse event is identified, we seek information to understand and report our findings to applicable regulatory agencies. We also communicate any safety issues to healthcare professionals and patients by updating the product labeling and providing other communications, as necessary. We may further evaluate the risks through additional studies, as needed.
In 2004, Biogen Idec launched TYSABRI® (natalizumab), a therapy shown to significantly reduce the rate of relapses or exacerbations and the risk of disability progression in patients with multiple sclerosis. In 2005, we voluntarily removed TYSABRI from the marketplace to investigate the occurrence of an infrequent, but serious and potentially fatal side effect, known as progressive multifocal leukoencephalopathy (PML). Through additional research, we determined that TYSABRI increases the risk of PML.
In 2006, the U.S. Food and Drug Administration (FDA) approved the reintroduction of TYSABRI in the United States, stating that the benefits of the product outweighed the risks. As part of the reintroduction, Biogen Idec worked with the FDA to create a restricted distribution program called TOUCH® (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program. TOUCH is a mandatory educational and monitoring program for physicians and patients in the United States to enable participants to be informed about the risk of PML and to help detect early signs suggestive of PML. The program promotes informed risk-benefit decisions between prescribers and patients. The therapy was also launched in the European Union the same year. In Europe, Biogen Idec provides physicians and patients with significant education on the risk of PML. In addition, patients in Europe can be enrolled in observational studies or registries to further monitor their safety. To learn more about TOUCH and TYSABRI, please visit www.tysabri.com.
In addition to the TOUCH program, Biogen Idec is conducting research to enable us to better identify patients who may be at higher risk for PML when they are considering or receiving treatment with TYSABRI. As reflected in our current product labeling, we have identified that the risk of PML goes up with longer TYSABRI treatment duration, especially after two years, and in patients treated with an immunosuppressant prior to receiving TYSABRI. We have also identified anti-JC virus antibody status to be an additional risk factor for developing PML. Infection with the JC virus (JCV) is required for the development of PML. Patients who test positive for anti-JCV antibodies, meaning that they have been exposed to JCV in the past, have a higher risk of developing PML.
- In June 2011, the European Commission (EC) approved the inclusion of anti-JCV antibody status in the TYSABRI product labeling in the EU as an additional factor to aid in stratifying patients at risk for developing PML. As part of a standard review process, the EC concluded that the quality, safety and efficacy of TYSABRI continue to be adequately demonstrated, and renewed the EU five-year Marketing Authorization.
- In January 2012, the FDA approved a product label change for TYSABRI that will help enable individual benefit-risk assessment for patients. The new label identifies anti-JCV antibody status as a third risk factor for developing PML and notes that anti-JCV antibody negative status indicates exposure to JCV has not been detected.
We are also continuing to identify additional factors to help stratify the risk of PML and are collaborating with other companies through a research consortium focused on the study of PML. We believe this approach provides patients and their physicians with additional guidance to help them make more personalized treatment decisions when considering TYSABRI. For more information about our therapies, including their benefits and risks, please see Therapies.
Biogen Idec aims to be a trusted source of information for our stakeholders, including patients and healthcare professionals. By engaging and listening, we strive to tailor our communications to better meet their needs and expectations.
For instance, we survey healthcare professionals periodically to ensure we are providing information that is of interest and best meets their needs. As an example, through these surveys, we learned that physicians prefer to receive monthly updates on TYSABRI. As a result, we are providing updates with this frequency, upon patient or physician request. We also survey healthcare professionals periodically to determine their satisfaction with our TYSABRI communications, both in terms of transparency and usefulness.