Intermune Inc. has received a positive recommendation from a US Food and Drug Administration (FDA) committee for its novel treatment for idiopathic pulmonary fibrosis (IPF), Esbriet (pirfenidone).

The decision by the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) was nine to three in favour of recommending approval. Decisions by such committees of the FDA do not guarantee approval but are typically a strong indicator of the final regulatory outcome. The decision was far from certain after concerns had earlier been raised over whether the drug was truly efficacious in treating IPF.

Investors reacted positively to the news, with Intermune shares surging and analysts speculating that the company could now be an acquisition target.

Ref: Intermune
http://phx.corporate...00827&highlight=

Ref: Reuters
http://www.reuters.c...dUSN0924859020100309

Clearing the way for approval?