InterMune (ITMN) shares soared over 60% in after-hours trading after a Food and Drug Administration panel voted in favor of its experimental drug pirfenidone for treatment of idiopathic pulmonary fibrosis, a fatal disease in which the lungs scar for no apparent cause. The FDA doesn't have to follow the panel's recommendation, although it usually does. The agency's decision is expected by May 4.
The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 9-3 to recommend approval of pirfenidone for the treatment of patients with IPF to reduce decline in lung function. While this vote passed by a wide margin, the vote on the drug's efficacy did not, because many panelists remain concerned that only one of the two trials showed clinical significance. The panel narrowly voted 7-5 in favor of pirfenidone providing a meaningful beneficial effect in the treatment of patients with IPF to reduce decline in lung function.
With such a narrow vote on the drug's effectiveness, some panelists acknowledged the difficulty of designing a trial for a fatal disease that has no cure. Moreover, several panelists said that considering there is no currently approved treatment and given the need to offer patients hope, they voted in favor despite not being entirely certain about efficacy, TheStreet.com reports.
While reversal of the disease may not be feasible due to the presence of fixed and irreversible fibrosis, the slowing of progression in loss of lung volume constitutes a clear benefit to patients. As for the drug's safety, the panel said there were fewer deaths in the treatment group compared to the placebo arm, but patients on pirfenidone had a higher rate of gastrointestinal side effects, among others.
"We are pleased with the outcome of today's Advisory Committee meeting," said Dan Welch, chairman, CEO and president of InterMune.
The FDA may grant priority review designation to pirfenidone if it deems it to have the potential to offer major advances in treatment, or provide a treatment where no adequate therapy exists -- which is the case with IPF.
IPF afflicts about 90,000 people in the U.S., making breathing progressively more difficult and typically leading to fatal respiratory failure within five years. The disease "represents an urgent, unmet medical need, for which there are no medicines approved by the FDA," InterMune said.
Trading in InterMune shares was halted Tuesday pending the panel's review. Last Friday, shares soared some 64% ahead of the reviews.
Pirfenidone would be InterMune's second approved drug. The FDA has granted the medicine orphan-drug and fast-track designation, and it has orphan-drug status in Europe as well. It is already approved in Japan. Orphan-drug status is meant to stimulate research and development of treatments for rare diseases affecting fewer than 200,000 people in the U.S. Fast-track designation can mean faster approval by the FDA for drugs that fill an unmet medical need in the case of serious or life-threatening diseases.
The stock closed at $23.30 Monday. At 6:36 p.m., it traded at $38.35, up $15.05, or 65%.
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