Enbrel Shipments Resume
Distribution of etanercept is still limited to patients who have already begun therapy with the product. New patients who wish to use etanercept must register with the Enbrel Enrollment Program and be put on a waiting list to receive the drug.
According to the letter, no new patients have been activated from the waiting list this year.
Supply problems had prompted Immunex to announce this past March that the company expected to temporarily halt deliveries of etanercept for "several days to a few weeks" during April and May. The July letter stated that additional disruptions of etanercept shipments are not expected in the foreseeable future.
Etanercept was approved in 1998 for the treatment of rheumatoid arthritis. An additional indication for the treatment of psoriatic arthritis was added to the product's labeling this year, potentially increasing demand for the drug.
Immunex announced in its 2000 and 2001 annual reviews that the company is renovating a manufacturing plant in Rhode Island and expects, pending Food and Drug Administration approval of the facility, to double the current production of the drug. A manufacturing agreement between Immunex and Genentech Inc. that was reached in April could further increase the supply of etanercept starting in 2004.
Immunex was acquired by Amgen Inc. on July 16. Amgen's corporate communications office has referred all calls about the distribution of etanercept to the Enbrel Enrollment Program (888-436-2735). A customer service representative with the enrollment program said that the acquisition of Immunex by Amgen has not affected the availability of etanercept.