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Arthritis Drug Misses New Indication Endpoint

By R&D Editors | July 9, 2014

Shares of Celgene Corp. slipped in premarket trading Wednesday after the drugmaker said its psoriatic arthritis treatment Otezla missed the main goal of a late-stage study exploring an additional use.
 
The Summit, New Jersey, company said Otezla did not achieve a statistically significant improvement when compared to a placebo in a study of patients with a painful spinal joint disorder called ankylosing spondylitis. But the drug did show signs of effectiveness in patients with early stages of the disease who took Otezla for a longer period, so research is continuing.
 
Celgene said it planned to start another late-stage study after it does more data analysis. Late-stage research is the final phase before a drugmaker submits a potential treatment to regulators for approval.
 
The Food and Drug Administration approved Otezla in March as a treatment for psoriatic arthritis, which causes joint pain, stiffness and swelling in patients with psoriasis.
 
Otezla is not approved to treat ankylosing spondylitis in any country.
 
Celgene shares fell $1.42, or 1.4%, to $84.30 shortly before markets opened. The stock had only climbed about 1.5% so far this year, as of Tuesday’s market close.
 
Date: July 9, 2014
Source: Associated Press

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