Immunex, Wyeth-Ayerst Pharmaceuticals regulatory update

The FDA approved IMNX's Enbrel etanercept to treat moderately to severely active rheumatoid arthritis in patients with inadequate responses to one or more disease modifying anti-rheumatic drugs or in combination with methotrexate in patients who do not respond to methotrexate alone (see BioCentury Extra, Nov. 3).

In addition, Wyeth-Ayerst, a division of American Home Products Corp. (Madison, N.J.), submitted an MAA to the European Medicines Evaluation Agency for Enbrel to treat moderate to severe rheumatoid arthritis. Wyeth-Ayerst, which holds North American co-promotion rights and exclusive marketing rights in the rest of the world, is developing Enbrel with IMNX. ...