FRA approves Avonex for relapsing form of MS.

The U.S. Food and Drug Administration has licensed the prescribing and marketing of Avonex(*) (interferon beta-1a) manufactured by Biogen of Cambridge, Massachusetts, to treat relapsing forms of MS.

The approval was based on results from a three-year study at five major MS treatment centers in the United States. The data show that this new drug slows increases in physical disability and reduces the number of acute attacks (or exacerbations) in people with relapsing forms of MS. It also reduces the number and size of active lesions (or areas of inflammation) in the brain, as shown on specially-enhanced MRI scans. Disability was measured with the Kurtzke Expanded Disability Status Scale (called the EDSS), a standard tool used in many studies of MS.(**)

"Avonex offers a new option for people with relapsing MS," said Dr. Stephen Reingold, vice president of Research and Medical Programs at the National MS Society. "The data show it has a positive impact on the disease and a favorable safety profile. The MS community welcomes this development."

The drug became available for prescription through retail pharmacies on May 20. The manufacturer sells a four-week supply to wholesalers for $710; the price consumers pay depends on wholesale and retail markup and health-plan coverage.

In the trial, Avonex significantly reduced the risk of an increase in physical disability by 37% over two years. It also reduced the number of acute attacks or exacerbations by 32% over two years. It did not reverse existing disability, and it does not cure MS.

Results in those taking the active drug were compared to what happened in control groups who injected a placebo, or inactive substance. During the study, neither participants nor health-care professionals knew who was in which group. This type of study is called a randomized, double-blind clinical trial.

Avonex is taken once a week, by injection into muscle tissues, or IM injection. In the trial the main side effects were short-term flu-like symptoms including fever, chills, muscle aches, and weakness, which diminished in frequency as treatment continued. These side effects, when they occured, generally resolved within 24 hours of an injection. There were no skin reactions at the injection site attributable to the drug. The small number of reactions that did take place were distributed equally among people injecting the inert placebo and the active drug.

Because Avonex requires IM injections, rather than an under-the-skin, or subcutaneous shot, there are some special issues regarding self-administration. Studies show that people may safely self-inject or receive Avonex injections from their carepartners if they have training and good medical follow-up.

The IM injection appears to be no more painful than other needle sticks. An individual's physician will determine if self-injecting is appropriate. Biogen, the manufacturer of Avonex, is sponsoring a comprehensive training program.

(*) Avonex is a trademark of Biogen, Inc.

(**) For a full report on the clinical trial, see LDJacobs et al, Annals of Neurology, V. 39, #3, March 1996.

Financial Issues and Avonex

The toll-free Avonex Support Line provides counseling on insurance reimbursement, information about distribution options that offer direct billing or "assignment of benefits", and some assistance for low-income uninsured people who could benefit from this medication.

When a person selects one of Biogen's distribution options, the distributor will bill the individual's health plan for the covered portion of the cost. The individual will be billed for deductibles and co-pay sums only. Medication and supplies can be picked up at a local pharmacy or delivered to a home or office, depending on the plan selected.

People with limited financial resources and no insurance will speak with counselors who will do individual evaluations in order to determine what options are possible. Free drug is available to qualified uninsured people.