Delays for Enbrel continue
New patients won't get arthritis drug until end of 2002, at earliest
First posted May 24, 2002
People who take etanercept (brand name Enbrel) for psoriatic arthritis will continue to face delays in getting their prescriptions filled, according to Seattle-based biotechnology company Immunex. The company reports it is not able to meet current demand for the drug.
The supply shortage also means that people who are on a waiting list to receive Enbrel will have to wait until the end of 2002 before they get it -- a delay that is six months longer than previously reported this spring.
For patients now taking Enbrel, there is a chance disease symptoms may return, depending on how long the delays last. Enbrel is a maintenance drug. Once it is stopped, disease symptoms return. In clinical trials, symptoms of arthritis generally returned within a month after patients stopped taking Enbrel.
The waiting game
Immunex and Wyeth Pharmaceuticals, Enbrel's manufacturing and marketing partners, have been requiring people to join a waiting list for the drug. Enbrel is being distributed on a first-come, first-served basis. Since December 2001, no one on the waiting list has been moved to the active list. Currently, there are 18,000 to 20,000 people on the waiting list.
Enbrel is made by a manufacturer in Germany. Due to an unexpected shortfall in a batch of the drug at the plant, Immunex announced in March that people currently taking the drug would experience delays in their prescriptions. Company executives sent letters to all 84,000 people with prescriptions for Enbrel explaining they might experience delays lasting "several days to a few weeks."
Those days and weeks are turning into months.
According to Immunex spokeswoman Robin Shapiro, the additional delay is due to the complexities of the approval process for a new manufacturing plant recently built in Rhode Island. The company has pushed back the date it will the U.S. Food and Drug Administration to approve the plant to "make sure we have the best data package," Ms. Shapiro said.
Once the Rhode Island plant is approved, the company expects to be able to double the present supply of Enbrel.
New option for psoriatic arthritis
Enbrel was approved by the U.S. Food and Drug Administration in January 2002 for the treatment of psoriatic arthritis. It was first approved for the treatment of rheumatoid arthritis in 1998.
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