Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Biogen Canada has received approval from Health Canada for Plegridy (peginterferon beta-1a)to treat adults with relapsing remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and to slow the progression of disability.
Subscribe to our email newsletter
Plegridy is a new molecular entity, resulting from the application of pegylation technology and it offers a new combination of demonstrated efficacy, a favourable safety profile consistent with the established interferon class and an every two-week dosing schedule.
The approval is based on Phase III data from the Advance (105MS301) study, one of the largest studies conducted with an interferon treatment in MS, which included 1,500 MS patients.
Multiple Sclerosis Clinic in London, Ontario, director Dr Marcelo Kremenchutzky said: "Plegridy is the first interferon dosed once every two weeks, which reduces the frequency of relapses and slows the progression of disability in people living with RRMS.
"Plegridy provides the safety profile we have come to expect from an interferon, with demonstrated efficacy and the added convenience of a reduced dosing schedule."
The pegylation technology prolongs circulation time by increasing molecular size resulting in a longer half-life, stabilizes the molecule by improving chemical stability and solubility for a longer shelf-life and shields from degradation and decreased immunogenicity.
The company noted that with this technology patients will receive an interferon treatment with less frequent dosing.
In the Advance trial, Plegridy reduced the risk of 12-week confirmed disability progression, as measured by the expanded disability status scale (EDSS), by 38%, compared to placebo.
The dug also significantly reduced the number of new or newly enlarging T2-hyperintense lesions compared to placebo.
Over the two years, the trial also showed low incidence of immunogenicity (NAbs) against IFN (anti-IFN NAbs).
Biogen Canada president and general manager Paul Petrelli said: "Biogen is a leader in the research and development of MS therapies because we understand that MS impacts every person differently and that each individual has distinct treatment needs driven by the severity of their MS, the impact of disease symptoms, their preferred route of administration and their lifestyle.
"The approval of Plegridy gives Canadian neurologists a new option to help address the unique needs of their patients."