An experimental drug for treating people with a rare lung disease has been passed for approval by a panel advising the US Government.
Health advisers voted to permit the use of pirfenidone, produced by the InterMune corporation, despite not having clear-cut evidence that it works for patients with idiopathic pulmonary fibrosis.
A panel of lung specialists at the Food and Drug Administration voted 9-3 to recommend the drug, after the panel voted 7-5 on a statement that pirfenidone has “clinically meaningful benefit” for patients who have the often-fatal disease. It is the first time a drug has been approved to treat it.
The department, which will decide on final approval by May 4, does not need to take the panel’s advice, although it normally does.
The fact that few options exist for patients with idiopathic pulmonary fibrosis seems to have convinced most of the panellists to give the go-ahead.
Panellist Karen Gottesman, who represents patients, said: “IPF is a fatal disease and you have to offer your patients hope. If this drug can offer your patients even a smidgen of hope, it’s worth approving.”
Copyright Press Association 2010
US Food and Drug Administration