Plegridy™ (PEGylated Interferon Beta)
Application submitted to FDA for approval of Plegridy™ (peginterferon beta-1a) in multiple sclerosis (21/05/13)
Biogen Idec has announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of Plegridy™ (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS).
“We believe that based on the efficacy and safety Plegridy has demonstrated, in addition to its less frequent dosing schedule, it has the potential to become a preferred interferon treatment option.”
This regulatory submission was based on the results from the first year of the two-year global Phase 3 ADVANCE study. The data demonstrated that Plegridy met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.
“This filing demonstrates our dedication to the treatment of MS, both through the discovery of new medications and the development of innovative solutions that enhance treatment for people living with this disease,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of Research and Development. “We believe that based on the efficacy and safety Plegridy has demonstrated, in addition to its less frequent dosing schedule, it has the potential to become a preferred interferon treatment option.”
In addition to the BLA filing with the FDA, Biogen Idec plans to submit a Marketing Authorisation Application (MAA) for Plegridy to the European Medicines Agency (EMA) in the coming weeks.
Biogen Idec has been the leader in the development of MS therapies for three decades and its robust treatment portfolio and development pipeline provides options that may help manage the disease from its earliest signs through its later stages.
The company anticipates hearing from regulatory authorities regarding the status and acceptance of these submissions within the next couple of months.
Plegridy is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule. Plegridy is a member of the interferon class of treatments and, if approved, would be a new addition to this class, which is often used as a first-line treatment for MS.
The two-year Phase 3 ADVANCE clinical trial is a global, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy and safety of Plegridy in 1,516 patients with relapsing-remitting MS.
The study investigates two dose regimens of PLEGRIDY, 125 mcg administered subcutaneously every two weeks or every four weeks compared to placebo. The analysis for all primary and secondary efficacy endpoints occurred at one year. After the first year, patients on placebo are re-randomized to one of the PLEGRIDY arms for the duration of the second year of the study. After completing two years in the ADVANCE study, patients have the option of enrolling in an open-label extension study called ATTAIN and will be followed for up to four years.
Source: Business Wire ©2013 Business Wire (21/05/13)
Biogen Idec Inc said its experimental multiple sclerosis drug peginterferon beta-1a reduced the annual relapse rate of patients with multiple sclerosis by 36 percent when dosed once every two weeks.
The company, which presented its results at the American Academy of Neurology's annual meeting, said the drug reduced the proportion of patients who relapsed by 39 percent compared with patients who took a placebo.
Peginterferon beta-1a, which will be marketed, if approved, under the brand name Plegridy, is an injectable drug designed to reduce the dosing schedule of standard interferon drugs such as Biogen's own Avonex, which are typically dosed at least once a week.
In addition to Avonex, Biogen makes the MS drug Tysabri, which is widely considered the most effective on the market but has been linked with a potentially deadly brain infection known as PML.
The company is also poised to launch a new MS drug, Tecfidera, a pill that many analysts believe could become the leading treatment for the disease.
The company hopes that Plegridy will provide an option for patients seeking a less frequent dosing schedule.
Biogen said the drug reduced the risk of 12-week disability progression by 38 percent compared with a placebo when given once every two weeks.
When given once every four weeks, Plegridy was also shown to be effective and met the main goals of the trial, but patients who received the drug once every two weeks responded better.
Multiple sclerosis is a chronic condition that occurs when the body's immune system mistakenly attacks and destroys the protective sheath surrounding nerve cells in the brain, optic nerve or spinal cord. Symptoms may include loss of balance, difficulty moving arms and legs, weakness, numbness and blindness.
Analysts expect the market for interferons to shrink over the next decade as newer generation products, especially pills such as Tecfidera.
Source: Reuters © Thomson Reuters 2013 (21/03/13)
Biogen Idec say that results from a third clinical trial for a multiple sclerosis drug called peginterferon beta-1a show that the drug can be a potential treatment dosed every two weeks or every four weeks for relapsing-remitting forms of the disease.
The drug is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and prolong its exposure in the body, enabling study of a less frequent dosing schedule.
“If approved, peginterferon beta-1a will represent an innovation that offers patients a less frequent dosing schedule of no more than 26 doses annually, as well as a significant reduction in relapses and disability progression,” said Gilmore O’Neill, vice president of global neurology late stage clinical development at Biogen Idec.
The study, called Advance, included more than 1,500 patients with RRMS and was designed to evaluate the efficacy, safety and tolerability of the drug compared to a placebo at one year. Results showed that when administered via subcutaneous injection, the drug demonstrated a significant reduction in annualized relapse rate at one year, officials said.
Based on data from the clinical trial, Biogen is planning regulatory submissions in the United States and Europe for the drug this year.
Source: Boston Herald.com © Copyright by the Boston Herald and Herald Media. 2013 (25/01/13)
Nuron Biotech Inc. said Tuesday it has completed enrollment of 500 patients for a pivotal phase-III study evaluating the safety and effectiveness of the company’s experimental multiple sclerosis treatment. Phase-III studies are typically the last hurdle a drug developer must clear before seeking approval for a new drug candidate. Nuron, an Exton, Pa., specialty biologics and vaccines company, is developing NU100 to treat relapsing remitting multiple sclerosis. Shankar Musunuri, the company’s founder and CEO, said it expects to complete the study in late 2013. The company hopes to use the results of the study to support the filing of a European marketing authorization application. Multiple sclerosis is an autoimmune disease in which a person’s own immune system mistakenly attacks normal tissues. An estimated 2.5 million people worldwide and 400,000 people in the United States have the condition. Source: Philidelphia Business Journal © 2012 American City Business Journals. (14/11/2012)