Biogen Idec announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of AVONEX(R) PEN(TM) for patients with relapsing multiple sclerosis (MS) and patients with a single demyelinating event. The CHMP recommendation provides the basis for a European Commission licensing decision, which is expected within 75 days from the opinion. The company also announced an authorisation for AVONEX PEN from Health Canada.
AVONEX PEN is designed to be the first single-use, once-a-week, fully integrated intramuscular autoinjector available for use with AVONEX treatment. It has been designed to improve convenience of AVONEX administration, while also reducing injection anxiety. The CHMP decision was based, in part, on a Phase 3b study in which the overall success rate in using AVONEX PEN in patients with MS was 89 percent. In the study, 94 percent of patients expressed a preference for AVONEX PEN over the AVONEX Prefilled Syringe.
“AVONEX is currently one of the most prescribed first-line treatments for people living with MS and has more than 1.4 million patient years of experience. For many patients and their caregivers, AVONEX PEN is a significant advancement, especially for those who desire a more convenient method of administration,” said Douglas E. Williams, Ph.D., executive vice president, research and development at Biogen Idec. “This positive CHMP opinion and authorisation in Canada is a testament to our commitment to not only develop new treatments for the MS community, but our continued drive to further improve patients’ experience with our existing industry-leading therapies.”
About AVONEX PEN
AVONEX PEN has been developed to be the first single-use, once-a-week, fully integrated intramuscular autoinjector available for use with AVONEX treatment in patients with relapsing MS, integrating the currently approved AVONEX Prefilled Syringe and utilizing a 25 gauge 16 mm (5/8 inch) needle specifically created for AVONEX PEN.
Additional features of AVONEX PEN will include a protective injector shield that conceals the needle prior to injection, automated needle insertion and medication delivery, and a diameter and length designed to stabilize AVONEX PEN during the injection procedure. In addition, AVONEX PEN will incorporate a safety lock, which helps prevent injection error, and a display window that confirms complete delivery of the medication.
The application in the European Union includes data from a Phase 3b open-label, multicenter study, which evaluated the safety and efficacy of AVONEX PEN. The study included patients with MS using AVONEX Prefilled Syringe for at least 12 weeks prior to enrollment (n=70). Efficacy of AVONEX PEN was assessed through objective and subjective assessments of key aspects of patients’ use of AVONEX PEN.
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. It is used worldwide as a treatment for relapsing forms of MS to slow the progression of physical disability and reduce relapses. AVONEX is also approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS.
The most common side effects associated with AVONEX MS treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported.
About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapeutic products for the treatment of serious diseases with a focus on neurological disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $4 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.