Tuesday, after the bell, InterMune Inc. (ITMN) announced that the Food and Drug Administration has issued a complete response letter for the New Drug Application for Esbriet (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis to reduce decline in lung function. In after-hours trading at one point of time, the stock fell as low as $8.28, about 82% down from Monday's closing price of $48.04.
Idiopathic pulmonary fibrosis, or IPF, which results in a progressive scarring of the lungs with no known cause, is a rare and fatal lung disease. There are no approved drugs in the U.S. or Europe to treat IPF, a disease, which is characterized by shortness of breath. The disease affects about 200,000 people in the U.S. and Europe.
The regulatory agency has requested the company to conduct an additional clinical trial to support the efficacy of Esbriet in IPF patients. InterMune said it intends to meet with the FDA as soon as possible to explore the best ways to address the points raised by the agency and to discuss pathways to approval.
On March 9, the Pulmonary-Allergy Drugs Advisory Committee of the FDA, which reviewed the New Drug Application for Esbriet voted 9-3 to recommend approval of the drug for the treatment of patients with idiopathic pulmonary fibrosis to reduce decline in lung function. The panelists also voted 7-5 that the drug provides a "clinically meaningful benefit".
InterMune is also seeking approval to market Esbriet for the treatment of IPF patients in the European Union. Esbriet has been granted Orphan Drug status for the treatment of IPF in Europe.
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