You are here

Multiple Sclerosis Drug Plegridy (Peginterferon) Submitted for FDA Review

Treatment significantly reduces disease activity in phase III trial (May 21)

A biologics license application (BLA) has been submitted to the FDA for approval of Plegridy (peginterferon beta-1a; Biogen Idec), a pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (MS).

The regulatory submission was based on results from the first year of the 2-year phase III ADVANCE trial involving 1,516 patients with relapsing-remitting MS. In this study, Plegridy met all primary and secondary endpoints at 1 year by significantly reducing disease activity — including relapses, disability progression, and brain lesions — compared with placebo, and showed favorable safety and tolerability profiles.

Plegridy is a new molecular entity in which interferon (IFN) beta-1a is pegylated to extend its half-life and to prolong its exposure in the body. (Pegylation is the process of covalent attachment of polyethylene glycol [PEG] polymer chains to another molecule.) The drug is a member of the IFN class of treatments and, if approved, would be a new addition to this class, which is often used as a first-line therapy for MS.

The ADVANCE trial is investigating two dosing regimens of Plegridy — 125 mcg administered subcutaneously every 2 weeks or every 4 weeks — compared with placebo. The analysis for all primary and secondary efficacy endpoints occurred at 1 year. After the first year, patients receiving placebo were re-randomized to one of the Plegridy arms for the duration of the second year of the study. After completing 2 years in the ADVANCE trial, the patients will have the option of enrolling in an open-label extension study (ATTAIN) and will be followed for up to 4 years.

Source: Biogen Idec; May 21, 2013.

Recent Headlines

Related Settlement Would End Many but Not All Lawsuits
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs
Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy
One in Five Kids’ Office Visits Results in an Off-Label Rx
Disrupting Gut Microbiome Could Be Key
Drug Boosts Levels of Natural Endocannabinoids
Judicious Use of Antibiotics May Not Be Enough To Defeat Bacteria That Carry On By Going Into a Dormant State
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds