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Plegridy™ (PEGylated Interferon Beta)

PEGylated Interferon Beta

 

 

 

 

 

 

 

FDA delays approval of Biogen Idec’s MS drug Plegridy(19/03/14)

The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of US biotech firm Biogen Idec’s Biologics License Application for Plegridy (peginterferon beta-1a), a subcutaneous pegylated interferon candidate for relapsing forms of multiple sclerosis (RMS).

The PDUFA date has been extended by three months, which is the standard extension period. The FDA has indicated that the extension of the PDUFA date is required to allow additional time for review of the application. The agency has not asked for additional studies, noted Biogen Idec.

Regulatory authorities in the USA and the European Union accepted the marketing applications for the review of Plegridy in RMS last year. Assuming that Plegridy comes to the market, it will add to Biogen Idec’s already strong MS franchise, which includes one of the leading drugs in the sector, Tysabri (natalizumab), as well as Avonex (interferon beta 1a) and more recently approved Tecfidera (BG-12, dimethyl fumarate), which many analysts have said could become the leading treatment for MS.

Source: The Pharma Letter © The Pharma Letter Limited 2014 (19/03/14)

Significant clinical and MRI improvements shown with PLEGRIDY(TM) (Peginterferon Beta-1a)(01/10/13)

Biogen Idec announced new data analyses from year one of the two-year, pivotal, Phase 3 ADVANCE study of PLEGRIDY(TM) (peginterferon beta-1a). PLEGRIDY is an investigational subcutaneous injectable for relapsing forms of multiple sclerosis (RMS), in which interferon beta-1a is pegylated to prolong the molecule's exposure in the body and enable the study of a less frequent dosing schedule. Clinical and MRI data from the study demonstrated a reduction in relapses, disability progression and the number of MS lesions when compared to placebo, and further support the clinical efficacy profile of PLEGRIDY. These data will be presented this week at the 29(th) Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark 2-5 October.

"If approved, PLEGRIDY could become a valuable addition to the interferon class of multiple sclerosis therapies," said Professor Peter Calabresi, MD, director, The Johns Hopkins Multiple Sclerosis Center. "The combination of efficacy demonstrated across key disease measures and a less frequent dosing schedule has the potential to offer an important therapeutic option for people living with MS."

Improvements Seen in Clinical and MRI Endpoints

Over one year, absence of measured disease activity (defined as no relapses, no disability progression, no gadolinium-enhancing [Gd+] lesions and no new or newly enlarging T2-hyperintense lesions compared to baseline) among patients, was significantly higher with PLEGRIDY: 34 percent in the two-week dosing arm (p<0.0001) and 22 percent in the four-week dosing arm (p=0.01), compared to 15 percent in the placebo arm.

In the intent-to-treat population of the ADVANCE study, PLEGRIDY, when dosed every two weeks, significantly reduced the number of new or newly enlarging T2-hyperintense lesions, new T1-hypointense lesions, new Gd+ lesions and new active lesions compared to placebo at 48 weeks. Specifically, PLEGRIDY reduced the number of:

-- New T1-hypointense lesions by 53 percent in the two-week dosing arm (p<0.0001) and 18 percent in the four-week dosing arm (p=0.082), ns

-- New active lesions by 67 percent in the two-week dosing arm (p<0.0001) and 35 percent in the four-week dosing arm (p<0.0001)

And, as previously reported at the American Academy of Neurology's 65(th) Annual Meeting in March 2013:

-- New or newly enlarging T2-hyperintense lesions by 67 percent in the two-week dosing arm (p<0.0001) and 28 percent in the four-week dosing arm (p=0.0008)

-- New Gd+ lesions by 86 percent in the two-week dosing (p<0.0001) and 36 percent in the four-week dosing arm (p=0.07), ns

"We believe the new analyses reinforce the efficacy of PLEGRIDY, which has been shown consistently across key MS disease measurements. They further support its potential as a treatment option for people living with this disease," said Gilmore O'Neill, vice president, Global Neurology Clinical Development at Biogen Idec. "The ADVANCE study results we have seen to date indicate that PLEGRIDY may have a positive effect on the reduction of relapses, disability progression and the reduction of lesion development."

Clinical and MRI results, including a post-hoc analysis evaluating the absence of measured disease activity from year one of the ADVANCE study, will be presented in the poster session titled, "Immunomodulation/Immunosuppression," on Thursday, 3 October at 3:45 p.m. -- 5:00 p.m. CET:

-- Peginterferon Beta-1a Provides Improvements in Clinical and Radiological
Disease Activity in Relapsing Multiple Sclerosis: Year 1 Findings from the Phase 3 ADVANCE Study (poster 514)

Additional MRI results from the first year of ADVANCE will be presented in the poster session titled, "II Immunomodulation/Immunosuppression," on Friday, 4 October at 3:30 p.m. -- 5:00 p.m. CET:

-- Magnetic Resonance Imaging Results from the First Year of the ADVANCE Study, a Pivotal Phase 3 Trial of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis (poster 989)

About PLEGRIDY

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. PLEGRIDY is a member of the interferon class of treatments, which is often used as a first-line treatment for MS.

Regulatory authorities in the United States and the European Union accepted the marketing applications for the review of PLEGRIDY in RMS in July 2013.

About ADVANCE

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.

In the ADVANCE clinical trial, PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity, including relapses and disability progression, compared to placebo, and showed favorable safety and tolerability profiles at one year. PLEGRIDY also reduced the number of new or newly enlarging T2-hyperintense lesions and the number of Gd+ lesions on brain MRI scans after 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: The Wall Street Journal ©2013 Dow Jones & Company, Inc (01/10/13)

US and EU regulatory authorities accept Plegridy(TM) (peginterferon beta-1a) marketing applications for review(22/07/13)

Biogen Idec announced that U.S. and EU regulatory authorities have accepted the marketing applications for the review of Plegridy(TM) (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec's Biologics License Application (BLA) for marketing approval of PLEGRIDY in the United States and granted the company a standard review timeline. The Marketing Authorisation Application (MAA) of Plegridy for review in the European Union was also validated by the European Medicines Agency.

The regulatory applications included positive one-year results from 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 favourable safety and tolerability profiles at one year.

"We expect that interferons will remain an important and widely used option for patients with MS. At one-year, Plegridy demonstrated significant reductions in relapses and disability progression, as well as a robust impact on several MRI endpoints," said Douglas E. Williams, Ph.D., Biogen Idec's executive vice president of Research and Development. "Plegridy, if approved, could offer a less frequent dosing schedule, a favorable safety profile, and the potential to become the preferred interferon treatment."

About Plegridy

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. Plegridy is a member of the interferon class of treatments, which is often used as a first-line treatment for MS.

Source: Market Watch Copyright © 2013 MarketWatch, Inc (22/07/13)

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.

About Plegridy

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.

About ADVANCE

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)

Injectable MS drug, peginterferon beta-1a, cut relapse rate by 36 percent(21/03/13)

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)

Positive results for peginterferon beta-1a in phase III trial(25/01/13)

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 closing in on new treatment for relapsing MS(14/11/2012)

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)