Biogen Idec secures FDA nod for Avonex delivery accessory

Biogen Idec ($BIIB) gained the FDA's go-ahead this week for a drug delivery advance and dosing change intended to improve how MS patients take Avonex. They are subtle yet significant ways intended to help the drug stand out in the marketplace as competition advances.

Avonex, a groundbreaking once-weekly treatment for relapsing multiple sclerosis when it first gained FDA approval in 1996, generated $2.7 billion of the company's $5 billion in revenue during 2011. That's a lot of dough, so consider that any tweaks or improvement to drug delivery technology can help preserve vital market share. It's like a new coat of paint or accessory, but with substantial revenue at stake.

FDA officials signed off on the company's Avonex Pen, which Biogen Idec bills as the first "intramuscular autoinjector" approved for MS. (Canada and the European Union approved the device last year.) It is meant to work better than the company's prefilled syringe and uses a much smaller needle. Think about it: Biogen Idec said it hopes this will reduce "injection anxiety" and "pain." Translated, that means patients will be more than likely to use the drug, versus a competitor, with a delivery mechanism that is painless and easy to use that automates injection doses.

Customers remain happy and coffers full, even as the company searches for a new MS blockbuster with BG-12, an oral treatment for which it is seeking an NDA with the FDA.

Separately, the FDA signed off on a dosing titration regimen where Avonex is escalated gradually once treatment starts, in order to cut back on side effects (flu-like symptoms) that can erupt when Avonex use starts. Dosing will be delivered over three weeks, expanded from 7.5 mcg to 15 mcg and then 22.5 mcg, with a full dose coming at the fourth week. Those may not seem like huge changes, but consider what FiercePharma told you last summer. It costs patients taking Avonex, as well as competing drugs made by Teva, Bayer and Merck, more than $800,000 annually on average to experience a year's worth of treatment. Do what you can to keep them happy, then, so they don't jump ship.

- here's the release

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