Immunex Temporarily Halts Etanercept Shipments
Immunex announced last month that shipments of etanercept would temporarily be delayed starting in late March or early April. In letters sent to pharmacists and patients, the company stated that the product could be unavailable for "several days to a few weeks" during April and May.
The company has limited the distribution of etanercept since January 2001 to patients who are already using the product, which was approved in 1998 for the treatment of rheumatoid arthritis. Patients must register with Immunex, through the company's Enbrel Enrollment Program, to join the waiting list and, eventually, receive the medication.
Etanercept was approved this past January for an additional indication, the treatment of psoriatic arthritis. About one million adults in the United States may suffer from psoriatic arthritis, according to a recent survey that was funded in part by Immunex and conducted for the National Psoriasis Foundation.
Rheumatoid arthritis and psoriatic arthritis patients must negotiate Immunex's waiting list.
"It doesn't matter what people are using Enbrel for," said Robin Shapiro, director of public affairs for Immunex. "They have to go through the same enrollment program to get access to the drug."
She added: "We have not activated any new patients off the [waiting] list since December."
According to the annual reviews released by Immunex for 2000 and 2001, the company's renovation of a large-scale manufacturing plant in Rhode Island has the potential to double the production of etanercept. Immunex said it expects the Food and Drug Administration to approve the production facility during the second half of 2002.