Dermatological Indications May Drive Humira Growth, Abbott Says
This article was originally published in The Pink Sheet Daily
An approval for psoriatic arthritis could occur in the second half of 2005; the supplemental BLA has an estimated user fee date in October. First quarter U.S. Humira sales were down from the previous quarter due to competition from Amgen/Wyeth's Enbrel and "disappointing" penetration of the early RA market, Abbott says.
You may also be interested in...
The company will launch the new delivery device by the end of November, one month ahead of schedule. Enbrel's growth has been driven by performance in psoriasis, where the product holds the vast majority of market share among biologics.
The TNF-inhibitor adds first-in-class claim for “major clinical response” in rheumatoid arthritis and gets approval for new once-weekly prefilled syringe. Five-year radiographic data also added to the label.
“We are prepared to enter discussions toward a decree at FDA’s earliest convenience,” Able says in letter to FDA. Company is pursuing consent decree instead of responding to FDA Form 483 report citing manufacturing deficiencies. The letter follows CEO Maury’s resignation the previous day.