FDA Approves Interferon Autoinjector for Multiple Sclerosis

Allison Shelley

March 02, 2012

March 2, 2012 — The US Food and Drug Administration (FDA) has approved a new autoinjector system and titration regimen for patients receiving once-a-week treatment with interferon beta-1a (Avonex, Biogen Idec) for relapsing forms of multiple sclerosis (MS).

In a statement, Biogen announced FDA approval for their Avonex Pen, an intramuscular autoinjector that integrates the currently approved prefilled syringe with a smaller needle, which at 25 gauges and 5/8 of an inch, is thinner and much shorter than what's available now. The aim is to reduce anxiety about self-injection, the company notes.

Avonex Pen

The new titration regimen, also approved by the FDA, incorporates an escalating dose designed to reduce the incidence and severity of flu-like symptoms commonly experienced when therapy with interferon begins. The optional schedule is based on data from an 8-week randomized, healthy-volunteer study of 234 people. After a 3-week titration period, the study showed the regimen reduced flu-like symptoms by 76%.

Interferon has been an effective treatment for multiple sclerosis for more than 15 years.

The interferon pen, which is already available in Europe and Canada, received regulatory approval in the United States on the basis of data from a phase 3 study. Investigators studied the efficacy and safety in an open-label, multicenter study of 70 patients. Approximately 9 of 10 patients used the autoinjector successfully. Of these, 94% expressed a preference for the 30 mcg/0.5 mL pen over the interferon prefilled syringe.

According to the prescribing information, interferon should be used with caution in patients with depression or mood disorders or seizures. Patients should also be monitored for signs of hepatic injury. Those with cardiac disease should be closely monitored. Routine periodic blood chemistry and hematology tests are recommended during treatment. Rare cases of anaphylaxis have been reported.

Complete prescribing information is available online.

"Interferon has been an effective treatment for multiple sclerosis for more than 15 years," Douglas Williams, PhD, Biogen Idec's executive vice president of research and development, said in a news release issued Tuesday. "Data have shown it to have the highest adherence rate among currently marketed injectable therapies," he pointed out. "However, anxiety around administration and the potential for flu-like symptoms can be a barrier for some patients."

Analysts say that with new oral therapies for MS entering the market, Biogen is working to hold on to its current market share for Avonex.

New Drug Application for BG-12

However, Biogen also announced Tuesday it has submitted a New Drug Application to the FDA for its own oral agent for MS, oral dimethyl fumarate, also known as BG-12.

A similar application to the European Medicines Agency is scheduled for the product in the coming days, the company notes.

BG-12 is the only investigational compound that has experimentally demonstrated activation of the Nrf-2 pathway, the Biogen statement says.

Although there have been significant advances in MS treatment in the past 15 years, "there is still a significant unmet need for new and innovative therapies that target the disease in different ways," Dr. Williams said in the statement. "Based on the robust clinical efficacy and safety data seen in our phase 3 studies, we believe BG-12 has the potential to become an important oral treatment option for multiple sclerosis patients."

As previously reported by Medscape Medical News, trial results from the DEFINE and CONFIRM studies were both positive.

The first study, Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) included 1234 patients and found treatment reduced by roughly half the proportion of patients who relapsed at 2 years compared with placebo.

In the second study, Results of the Comparator and an Oral Fumarate in RRMS (CONFIRM) trial included 1430 patients and showed the drug significantly reduced annualized relapse rates vs placebo and compared favorably with a reference group treated with glatiramer acetate (Copaxone, Teva Pharmaceuticals).

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