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PLEGRIDY (peginterferon beta-1a) receives SMC approval for the treatment of relapsing remitting multiple sclerosis

PLEGRIDY® ( beta-1a) has been approved by the (SMC) as a treatment for adults with relapsing- remitting (RRMS).1

Peginterferon beta-1a is the only approved pegylated treatment for MS. Utilising the pegylation process allows patients to receive the benefits of an with fewer injections, which may be an attractive option for patients with RRMS seeking such a benefit. Less frequent dosing is one of the factors which have been associated with improved adherence to disease- modifying therapies in patients with relapsing-remitting multiple sclerosis.2

As well as pegylation allowing less frequent dosing, it also allows peginterferon beta-1a to be stored outside a refrigerator at room temperature (up to 25°C) for up to 30 days (but it must be kept away from light) 3 offering flexibility to patients in terms of how they store their medication.

Peginterferon beta-1a has demonstrated an efficacy and safety profile consistent with the established interferon class. It is dosed fortnightly and is administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector. Other disease modifying treatments for multiple sclerosis are dosed between one and seven times a week.4 Data from patients treated up to 2 years with peginterferon beta-1a suggests that less than 1% (5/715) developed persistent- neutralising antibodies (which can reduce clinical efficacy) to the interferon beta-1a portion of peginterferon beta-1a.3

Dr James Overell, Consultant neurologist, South General Hospital, Glasgow said, “PLEGRIDY offers a strong efficacy and safety profile, with the additional benefits of a fortnightly dosing schedule and a convenient method of administration where patients don’t need to see the needle.

It represents a suitable option for appropriate newly diagnosed patients or patients with tolerability and compliance issues considering a switch from other injectable or oral agents.”

The SMC approval of peginterferon beta-1a is based on results from one of the largest pivotal studies of a conducted, ADVANCE5, which involved more than 1,500 patients with RRMS.

In the ADVANCE clinical trial, peginterferon beta-1a, dosed once every two weeks, significantly reduced annualised relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007). Peginterferon beta-1a reduced the risk of sustained disability progression confirmed at twelve weeks by 38 percent (p=0.0383) and at twenty four weeks by 54 percent (p=0.0069, post-hoc analysis). In addition, the number of gadolinium-enhancing [Gd+] lesions was significantly reduced by 86 percent (p<0.0001) compared to placebo.

Results over two years of ADVANCE confirm that its efficacy was maintained beyond the placebo-controlled first year of the study.