Abbott rival of Amgen's Enbrel gets OK from FDA
Seattle Times business reporter
The FDA approved Humira, which aims to reduce pain and joint damage in patients with moderate to severe rheumatoid arthritis. The go-ahead came nine months after the company sent in its drug application, meaning Humira can compete sooner than expected.
Clinical trials have shown that the drug is effective in about two-thirds of patients and has few side effects other than potentially making some patients susceptible to infections. The drug is about as safe and effective as Enbrel, developed by Seattle-based Immunex and approved by the FDA as the first drug of its kind.
Humira and Enbrel are made of genetically engineered proteins that zero in on and neutralize overproduced proteins that cause inflammation.
Both can be taken alone or in combination with methotrexate, a chemotherapy drug. Abbott said it will price the drug almost identically to Enbrel, at $1,100 a month wholesale.
Abbott, based in suburban Chicago, says it will have an edge, however, because patients need injections only twice a month instead of twice a week for Enbrel. Amgen has begun testing Enbrel in once-a-week injections and is touting its five-year track record in more than 130,000 patients.
Enbrel was approved in November 1998 and has been projected to reach $800 million in sales for 2002. Amgen assumed control of the drug when it bought Immunex in July, and just last week won critical FDA approval for a new factory that should double the capacity to make the drug. A two-year shortage of Enbrel created an opportunity for competitors like Humira and Johnson & Johnson's Remicade to catch up.
Abbott Laboratories said it has already looked ahead at manufacturing. It has an FDA-approved factory in Massachusetts that it thinks can make at least $1 billion worth of Humira a year. The company said the first shipments of the drug will be ready next week.
"We think Humira brings a lot of new possibilities to patients," said Abbott spokeswoman Cindy Resman. "Its effectiveness is at least as good as the competition, and it has a dosing advantage."
An Amgen spokesman could not be reached for comment.
Like Enbrel, Abbott believes Humira may work for a whole class of inflammatory diseases besides rheumatoid arthritis, which afflicts 2 million Americans.
Abbott also is running or planning to run clinical trials for Humira in juvenile rheumatoid arthritis, Crohn's disease, psoriasis, psoriatic arthritis, and the spinal inflammatory disease ankylosing spondylitis.
Luke Timmerman: 206-515-5644 or firstname.lastname@example.org.