Author Topic: PLEGRIDY approved for RRMS by Scottish Medicines Consortium  (Read 158 times)

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Offline agate

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PLEGRIDY approved for RRMS by Scottish Medicines Consortium
« on: January 18, 2015, 07:08:08 pm »
From Medical News Today, January 15, 2015:

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

PLEGRIDYŽ (peginterferon beta-1a) has been approved by the Scottish Medicines Consortium (SMC) as a treatment for adults with relapsing- remitting multiple sclerosis (RRMS).

Peginterferon beta-1a is the only approved pegylated treatment for MS. Utilising the pegylation process allows patients to receive the benefits of an interferon treatment 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.

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)  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.

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 beta interferon 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.

"Biogen Idec wholeheartedly welcomes the SMC decision" said Terry O' Regan, Vice President and Managing Director of Biogen Idec in the UK & Ireland. "We are committed to improving the lives of people with MS by developing innovative therapies and providing greater choice and flexibility in terms of disease management. Today's recommendation for Plegridy is supportive of this aspiration."

The safety and tolerability profile of peginterferon beta-1a observed in ADVANCE was consistent with that of established MS interferon therapies. The most commonly reported adverse drug reactions with peginterferon beta-1a treatment (incidence ≥10% and at least 2% more frequent on peginterferon beta-1a than on placebo) were injection site reaction, flu-like illness, fever, headache, muscle pain, chills, injection site pain, weakness, injection site itching, and joint pain.

Peginterferon beta-1a is the fifth therapy to be offered by Biogen Idec to people living with MS, expanding on a comprehensive portfolio that addresses individual patient needs at every stage of their disease.

About PLEGRIDY (peginterferon beta-1a)

Peginterferon beta-1a is a subcutaneous injectable therapy for RRMS, in which interferon beta- 1a is pegylated to permit a less frequent dosing schedule. It is a pegylated interferon beta-1a.

According to the Summary of Product Characteristics (SmPC), the recommended starting dose of peginterferon beta-1a is 63 micrograms at dose 1, increasing to 94 micrograms at dose 2, reaching the full dose of 125 micrograms by dose 3 and continuing with the full dose (125 micrograms) every 2 weeks thereafter.

The safety and tolerability profile of peginterferon beta-1a observed in ADVANCE was consistent with that of established MS interferon therapies. It should be administered with caution to patients with previous depressive disorders, seizures, severe hepatic impairment and In addition, the EU SmPC indicates that the use of interferon beta products is associated with cases of nephrotic syndrome, thrombotic microangiopathy manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), hyper and hypothyroidism, hepatitis, autoimmune hepatitis, rare cases of severe hepatic failure, and decreased peripheral blood counts, including rare pancytopenia.

About Pegylation

Pegylation prolongs the circulation time of the molecule in the body by increasing its size, thus enabling a longer half-life, stabilising the molecule by improving its solubility and shielding the molecule from enzymes in the body that try to break it down into smaller particles. Pegylation is a well-established scientific process for medicinal use.

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