Disease-Modifying Drugs for MS: New Single-Use, Auto-Injection Device Approved
As of January 2013, the FDA has approved nine disease-modifying drugs or therapies (listed below) for the treatment of relapsing forms of multiple sclerosis, including secondary-progressive MS in patients who still experience relapses. One of the drugs, Novantrone, is specifically approved to treat secondary-progressive MS. Four drugs, Avonex, Betaseron, Copaxone, Extavia, are approved for use in patients who have experienced a first clinical episode, called clinically isolated syndrome (CIS), and have MRI features consistent with MS. No drug is approved to treat primary-progressive MS.
• Betaseron (interferon beta-1b) - 250 mcg, taken every other day by subcutaneous (under the skin) injection; manufactured by Bayer HealthCare Pharmaceuticals, Inc.; FDA approval in 1993
• Avonex (interferon beta-1a) - 30 mcg, taken once a week by intramuscular (into the muscle) injection; manufactured by Biogen Idec; FDA approval in 1996
• Copaxone (glatiramer acetate) - 20 mg, taken every day by subcutaneous (under the skin) injection; manufactured by Teva Pharmaceuticals Industries, Ltd.; FDA approval in 1996
• Novantrone (mitoxantrone) - 12 mg/m2, taken four times a year by intravenous (IV) infusion in a medical facility with a lifetime cumulative dose limit of approximately 8–12 doses over 2–3 years (140 mg/m2); manufactured by EMD Serono, Inc./Immunex Corporation; FDA approval in 2000; available as generic drug since 2006
• Rebif (interferon beta-1a) - 44 mcg, taken three times a week by subcutaneous (under the skin) injection; manufactured by EMD Serono, Inc./Pfizer, Inc.; FDA approval in 2002
• Tysabri (natalizumab) - 300 mg, taken every four weeks by intravenous (IV) infusion in a registered infusion facility; manufactured by Biogen Idec/Elan Pharmaceuticals, Inc.; FDA approval in 2006
• Extavia (interferon beta-1b) - 250 mcg, taken every other day by subcutaneous (under the skin) injection; manufactured by Novartis Pharmaceuticals Corp.; FDA approval in 2009
• Gilenya (fingolimod) - 0.5 mg, taken every day by oral capsule; manufactured by Novartis Pharmaceuticals Corp.; FDA approval in 2010
• Aubagio (teriflunomide) - 7 mg or 14 mg, taken every day by oral tablet; manufactured by Genzyme, a Sanofi company; FDA approval in 2012
Five MS disease-modifying medications, Avonex, Betaseron, Copaxone, Extavia, and Rebif, are given as injections either under the skin or into the muscle by the patient or caregiver. Tysabri and Novantrone are given by intravenous infusion at a qualified infusion facility by trained professionals. Gilenya and Aubagio are drugs taken orally.
Since the approval of the first disease-modifying drug in 1993, the delivery method of the injectable medications for MS has improved with the development of pre-filled syringes and auto-injection devices. Initially medications required mixing before they were ready to be injected. Avonex, Betaseron, and Extavia are available in powered form requiring reconstitution.
The pre-filled syringe was designed to eliminate the need for mixing medication and for easy of use. Avonex, Copaxone, and Rebif are available in pre-filled syringes. To assist patients who may have difficulty reaching certain areas of the body for injection, or who have limited dexterity, or who may have a needle-phobia, auto-injection devices are available for use with syringes. Manufacturers of Betaseron, Copaxone, and Rebif provide auto-injection devices for use with their medication which are designed to be reused and loaded with new syringes for each injection.
A new trend in self-injection technique and methodology is the single-use (disposable), pre-filled autoinjector or pen which comes preassembled, loaded with medication, and ready to use. The Avonex® Pen™ was approved in February 2012 and just last week the FDA approved the Rebif® Rebidose® pen. With both the Avonex and Rebif pens, the needle remains covered both before and after injection. The Avonex® Pen™ is the first intramuscular (IM) autoinjector device approved for MS which incorporates a smaller needle and helps to reduce anxiety about self-injections.
A representative for EMD Serono shared with me that the Rebidose® pen was tested for ease of use, functional reliability, and patient satisfaction and acceptability during a 12-week, multicenter, open-label study in patients who had already been using full-dose Rebif (44 mcg) prior to the start of the trial. Results of the user trial “showed that the majority of patients found the device easy to use.” The Rebidose® pen was launched in Europe in 2010 and will be available in the US in early 2013. In the US, Rebif Rebidose® will be available in a monthly pack in two different doses, 22 mcg and 44 mcg, and in a titration pack.
Question: Do you have experience using auto-injection devices with your MS disease-modifying medication? If so, what is your experience? Would the availability of a single-use, pre-filled, hidden-needle, auto-injection device influence your ability to remain adherent to your disease-modifying drug of choice?
For More Information:
Biogen Idec Press Release, February 28, 2012: FDA APPROVES AVONEX® PEN™ AND DOSE TITRATION REGIMEN: Dosing Enhancements May Improve Treatment Experience for Patients Receiving AVONEX® (interferon beta-1a) for Multiple Sclerosis. Accessed at http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1666473
Merck Serono Press Release, January 3, 2013: Merck Serono Announces FDA Approval of Rebif® Rebidose® (interferon beta-1a). Accessed at http://www.prnewswire.co.uk/news-releases/merck-serono-announces-fda-approval-of-rebif-rebidose-interferon-beta-1a-185540042.html
National Multiple Sclerosis Society (2012). The MS Disease-Modifying Medications (pdf) Accessed at http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/download.aspx?id=45
Bayer HealthCare. Learn to Inject Betaseron® with Confidence. Accessed at http://www.betaseron.com/betaplus/how-to-inject