Late Friday afternoon, August 15, 2014, the Food and Drug Administration (FDA) gave Biogen’s PlegridyTM (peginterferon beta-1a) a green light (i.e., approval) for use in relapsing forms of multiple sclerosis. This new drug, basically an improvement on two longtime gold standard medications, Avonex and Rebif, is a longer-acting formulation of interferon beta-1a that is given by subcutaneous (under the skin) injection every two weeks, compared to Rebif’s subcutaneous injections three days each week and Avonex’s intramuscular injection once weekly.
Plegridy was approved in Europe on July 23, 2014 for treatment of relapsing-remitting MS (RRMS). It comes in a prefilled syringe or a new ready-to-use autoinjector called the Plegridy Pen.
In July, Mat Hesser, Director of Biogen Idec’s Patient Center of Excellence, told me that Biogen will continue to produce Avonex but may spend less time actively promoting it. As Biogen now offers four of the eleven drugs approved for MS, in addition to Fampyra outside the US, they are undoubtedly the leading MS-focused pharmaceutical company serving the MS community worldwide.
During our discussion, I mentioned to Mat an ongoing concern that there is lack of awareness for financial assistance programs in the US to help patients access treatments. I am pleased to see that Biogen’s press release regarding Plegridy’s approval clearly references Biogen’s patient support programs, including financial support, available through MS ActiveSource. [Disclaimer: I have served as a patient advisor to Biogen in recent years reviewing educational and support materials developed for MS patients.]
Plegridy in the ADVANCE Study
The FDA approval of Plegridy is based on results from the two-year, Phase 3, placebo-controlled (in year one) study, called the ADVANCE study, which involved more that 1500 people with RRMS. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one, after which all participants received Plegridy for the duration of the study. In the first year of the ADVANCE clinical trial, Plegridy dosed once every two weeks and compared to placebo:
- significantly reduced annualized relapse rate (ARR) at one year by 36 percent (p=0.0007);
- reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 38 percent (p=0.0383)
- significantly reduced the number of new gadolinium-enhancing [Gd+] lesions by 86 percent (p<0.0001); and
- significantly reduced new or newly enlarging T2-hyperintense lesions by 67 percent (p<0.0001).
The most common adverse reactions were injection site reaction, flu-like illness, fever (pyrexia), headache, muscle pain (myalgia), chills, injection site pain, weakness (asthenia), injection site itching (pruritus) and joint pain (arthralgia). The ADVANCE two-year safety data were consistent with safety results observed in year one.
So Many Choices for MS Patients
I remember when I was first diagnosed with MS and Rebif had recently been approved. Prior to that the disease-modifying therapies (DMTs) were known as the ABCs, short for Avonex, Betaseron, Copaxone. When Rebif joined the arsenal, the DMT nomenclature became the CRABs for Copaxone, Rebif, Avonex, Betaseron.
Now with 11 drugs available, perhaps someone could come up with a clever and memorable mnemonic to accommodate the various options listed below.
- Aubagio (teriflunomide) is made by Sanofi-Genzyme and taken once daily as an oral tablet. Visit aubagio.com or MSOnetoOne.com for more information.
- Avonex (interferon beta-1a) is made by Biogen Idec and delivered by intramuscular injection once per week. Visit avonex.com or msactivesource.com for more information.
- Betaseron (interferon beta-1b) is made by Bayer Healthcare and delivered by subcutaneous injection every other day. Visit betaseron.com for more information.
- Copaxone (glatiramer acetate) is made by Teva Neuroscience and delivered by subcutaneous injection every day for the 20 mg/mL dose or 3 days each week for the 40 mg/mL. Visit copaxone.com or sharedsolutions.com for more information.
- Extavia (interferon beta-1b) is made by Novartis and delivered by subcutaneous injection every other day. It is chemically the same as Betaseron. Visit extavia.com for more information.
- Gilenya (fingolimod) is made by Novartis and taken once daily as an oral capsule. Visit gilenya.com for more information.
- Novantrone (mitoxantrone) is made by EMD Serono and delivered by intravenous infusion once every 3 months with a lifetime maximum limit of 8-12 doses. Visit http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/medications/mitoxantrone/index.aspx for more information.
- Plegridy (peginterferon beta-1a) is made by Biogen Idec and delivered by subcutaneous injection every two weeks. It is chemically similar to Avonex and Rebif, but chemically altered to release more slowly in the body. Visit plegridy.com or msactivesource.com for more information.
- Rebif (interferon beta-1a) is made by EMD Serono and delivered by subcutaneous injection three days each week. It is chemically similar to Avonex. Visit rebif.com or mslifelines.com for more information.
- Tecfidera (dimethyl fumarate) is made by Biogen Idec and taken as an oral capsule twice daily. Visit tecfidera.com or msactivesource.com for more information.
- Tysabri (natalizumab) is made by Biogen Idec and delivered by intravenous infusion once every four weeks at a registered infusion center. Visit tysabri.com or msactivesource.com for more information.
Other MS drugs which the MS community is waiting for the FDA to approve include generic versions of daily Copaxone and Lemtrada (alemtuzumab), a humanized monoclonal therapy which binds to CD52, a protein found on mature lymphocytes, and is administered as IV infusion on 5 consecutive days followed by 3 infusions one year later. However, once Lemtrada has been given, there is no known way to remove it from one’s immune system. The FDA has taken the position that Genzyme, makers of Lemtrada (also known as Campath) has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.
Source: Biogen Idec Press Release
Emrich, Lisa. Hot Topics and MS Research News for July 2014. HealthCentral.com, July 28, 2014. Accessed August 18, 2014.
Emrich, Lisa. Medications for MS: What’s the difference between interferon beta-1a and interferon beta-1b? HealthCentral.com, December 1, 2010. Accessed August 18, 2014.
Emrich, Lisa. Redefining MS. HealthCentral.com, June 7, 2014. Accessed August 18, 2014.
Emrich, Lisa. Slowing Down the Long-Term Progression of Multiple Sclerosis by Using Disease-Modifying Therapies (DMTs). HealthCentral.com, November 20, 2013. Accessed August 18, 2014.
Emrich, Lisa. When to Consider Changing Treatments. HealthCentral.com, November 20, 2011. Accessed August 18, 2014.
Published On: August 18, 2014