MS drug Plegridy (peginterferon beta-1a)

 
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PostPosted: Sun Mar 31, 2013 6:20 pm    Post subject: MS drug Plegridy (peginterferon beta-1a) Reply with quote

From Medical News Today, March 21, 2013:

Quote:
Excellent Results For MS Drug "Plegridy"



Biogen Idec has just announced its final first year results of the Phase 3 trial of its relapsing-remitting multiple sclerosis drug Plegridy (peginterferon beta-1a). The drug met all primary and secondary endpoints of the trial results indicating that it is very effective at reducing multiple sclerosis (MS) disease activity.

MS is a an autoimmune disease in which the immune system begins to attack the brain and spinal cord (central nervous system). Symptoms include weakness, inability to move arms or legs, loss of balance, and numbness.

Plegridy is a member of the interferon class of drugs, which are often used as first line treatment for MS. It works by extending the half-life and exposure of interferon beta-1a in the body. According to a previous study, published in the Archives of Neurology, interferon treatment is able to achieve and sustain a response as measured by regular magnetic resonance imaging evaluations.

The results, which were presented at the American Academy of Neurology's 65th Annual Meeting, revealed that in comparison to placebo, Plegridy reduced the annual relapse of patients with multiple sclerosis by 36 percent and reduced the proportion of patients who relapsed by 39 percent.

The Phase 3 ADVANCE clinical trial was a two-year-long study which aimed to evaluate the efficacy and safety of Plegridy in more than 1,516 randomized patients suffering from MS. It evaluated the effectiveness of two different doses of the drug given either every two or four weeks.

Peter Calabresi, M.D., director, the Johns Hopkins Multiple Sclerosis Center, said:


"These full first-year results provide a more complete picture of PLEGRIDY and its positive effects on the reduction of relapse, disability progression and lesion development. These data suggest that, if approved, PLEGRIDY may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS."


Plegridy, dosed once every two weeks, showed numerically greater treatment effect than when dosed once every four weeks.

Gilmore O'Neill, Vice President, Global Neurology Late Stage Clinical Development at Biogen Idec, said:


"In the first year of the ADVANCE trial, PLEGRIDY demonstrated strong efficacy. We saw a marked reduction in relapse rate and this was supported by MRI results. If approved, PLEGRIDY will make an important therapeutic option in the injectable treatment segment. In addition to these encouraging therapeutic results, PLEGRIDY may reduce the treatment burden for patients by reducing the number of subcutaneous injections."


Adverse events of the drug included redness at the area of the injection as well as influenza-like symptoms. However, overall, the drug performed well in terms of safety, with the number of adverse events among those taking Plegridy similar to those on placebo.

Written by Joseph Nordqvist
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PostPosted: Sat May 25, 2013 2:18 pm    Post subject: Pregridy submitted to FDA for approval Reply with quote

A press release from Medical News Today, May 23, 2013:

Quote:
Biogen Idec Submits Application To FDA For Approval Of Plegridy™ (Peginterferon Beta-1a) In Multiple Sclerosis

EMA Submission Planned in the Coming Weeks

Biogen Idec (NASDAQ: BIIB) 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).

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.

...

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.

References:
Biogen Idec
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PostPosted: Sun Aug 11, 2013 6:14 pm    Post subject: Reply with quote

From News-Medical.net, July 19, 2013:

Quote:
Biogen Idec announces acceptance of marketing applications for review of PLEGRIDY

Today Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the marketing applications for the review of PLEGRIDY™ (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.

“PLEGRIDY, if approved, could offer a less frequent dosing schedule, a favorable safety profile, and the potential to become the preferred interferon treatment.”

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 favorable 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."

SOURCE Biogen Idec


The article can be seen here.
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