Monday, June 10, 1996
BETHESDA, Md. - An FDA advisory panel unanimously recommended Friday that the agency approve Cephalon Inc.'s application for a Treatment IND for the use of Myotrophin (IGF-1) by ALS patients. But panel members also put CEPH on notice that they might not vote to approve an NDA without additional trials, which the company stated it does not intend to perform.
Following the meeting, Frank Baldino Jr., CEPH president and CEO, told BioCentury that the company will file an NDA for Myotrophin this summer based on the same trials presented at the meeting.
In the meantime, he said, the company will not seek to recover costs from distribution of Myotrophin prior to obtaining marketing approval.
Quick review promised
Robert Temple, chief of FDA's division of drugs, told BioCentury that the NDA will be reviewed in less than six months and will be referred back to the Peripheral and Central Nervous System Drugs Advisory Committee. He noted that the panel clearly wants another trial and acknowledged that patient pressure to approve Myotrophin is very strong. "It's anyone's guess," about what will happen at the next meeting, Temple said.
He also said the FDA is likely to comply with the committee's recommendation for the NDA.
Neither CEPH nor partner Chiron Corp. opened for trading on Friday, but investors dumped both stocks during the week (see Ebb & Flow, page A7).