Protein Design Labs
Wednesday said it will not pursue accelerated approval from the Food and Drug Administration for its drug Nuvion, which was granted fast-track status last year.
The results of a 32-patient phase I trial showed that Nuvion, although effective, caused flu-like symptoms, a decline in T-cell levels and a rise in liver enzymes. The symptoms were transient and typically subsided after the second day of treatment, the company said.
Nuvion is being tested as a treatment for a type of ulcerative colitis, a chronic condition causing colorectal inflammation and ulcers. PDL met with the FDA to discuss results of initial trials reported last May and will conduct additional testing before moving to the final, or phase III, stage.
In September of last year, the Fremont, Calif.-based company announced that the FDA had granted Nuvion "fast track" status, which allows for expedited development and review of drugs intended to treat a serious or life-threatening condition, unaddressed by drugs already on the market.
"Time to complete the proposed registrational studies will be longer than we have previously hoped," the company said. "Nuvion continues to be our highest priority program and we are committed to making this novel therapy available." PDL said it expects to provide an update on the situation by the end of May.
Shares fell 26 cents, or 1.6%, to $16.30.