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Pulmonary Fibrosis

Pirfenidone

02/05/2009

Question:

Dear Doctor, please update pirfenidone status after Intermune release. Paying attention that it has Oprah status when it may be available for prescription in USA, thanks.

Answer:

On February 3, 2009, Intermune Pharmaceuticals released the results of the phase III studies of pirfenidone in early stage idiopathic pulmonary fibrosis. There were two studies done simultaneously: CAPACITY 1 and CAPACITY 2.

The CAPACITY 1 study did not show a statistically significant change in pulmonary function but the CAPACITY 2 study did show that pirfenidone slowed the loss of lung function compared to placebo.

Importantly, pirfenidone did not stop the disease, it just slowed it down. Intermune will now submit an application to the Food and Drug Administration and the FDA has agreed to do a "fast track" designation for pirfenidone meaning that pirfenidone will move through the approval process faster than non-fast track medications.

Drugs that are approved through the "fast track" take about 6 months for approval. There is no guarantee that the FDA will approve pirfenidone. If both the CAPACITY 1 and CAPACITY 2 studies had showed significant benefit by pirfenidone then the chances of FDA approval would be higher.

If the FDA approves it, the earliest that pirfenidone would be available in the United States would be approximately summer of 2009. At present, pirfenidone is commercially available only in Japan.

From the available information, it appears that pirfenidone is not a cure for idiopathic pulmonary fibrosis; it only appears to slow down the course of the disease. Also, the CAPACITY studies only looked at patients with early stage disease and it would seem that the patients with the best chance of getting a benefit from pirfenidone are those with the earliest stages of idiopathic pulmonary fibrosis. It is unknown whether patients in later stages of the disease will get any benefit.

For more information:

Go to the Pulmonary Fibrosis health topic, where you can:

Response by:

James N Allen, Jr, MD James N Allen, Jr, MD
Clinical Professor of Pulmonary, Allergy, Critical Care & Sleep Medicine
College of Medicine
The Ohio State University