FDA Approves Forest Laboratories Drug To Treat Lung Disease

The Food and Drug Administration approved a new type of drug by Forest Laboratories Inc. (FRX) to treat a form of chronic obstructive pulmonary disease, or COPD.

The drug, Daliresp, is a pill taken once daily and works by inhibiting an enzyme called phosphodiesterase 4, which is believed to play a role in the inflammatory process involved with airway constriction. It falls into a new category of drugs known as PDE-4 inhibitors.

The FDA said Daliresp is meant for people with severe COPD linked to bronchitis and isn't intended to treat another form of COPD caused by emphysema. Daliresp is also meant to be used long term to reduce the frequency of flare-ups caused by COPD and isn't meant to treat acute attacks, which are usually marked by difficulty breathing.

COPD is a group of lung conditions such as emphysema and chronic bronchitis that cause a narrowing of airways in the lungs, making it difficult to breathe. COPD, often caused by cigarette smoking, is the fourth-leading cause of death in the U.S.

Last year, the FDA initially declined to approve Daliresp, also known by its generic name roflumilast, following a negative vote by an advisory panel of non-FDA medical experts. The agency then asked Forest for more information, which was later submitted.

During the panel review of roflumilast, the FDA said the effectiveness of drug appeared to be "quite modest." The agency also said there were psychiatric side effects seen in clinical studies of the drug, along with gastrointestinal side effects such as diarrhea and nausea.

The FDA said Tuesday that the "safety and effectiveness" of the product was demonstrated.

"COPD is a serious disease that gets worse over time," said Curtis Rosebraugh, a director of an FDA drug-evaluation office. "New treatment options that reduce frequency of flare-ups or exacerbations are important in helping patients with COPD associated with chronic bronchitis."

Daliresp was approved with a so-called medication guide that will be given to patients outlining the risks of mental-health problems and unexplained weight loss.

Another company, Nycomed, submitted the application for Daliresp to the FDA, but it was transferred to Forest in late 2009. Forest said Daliresp would be available in the second quarter. The product is sold under the brand name Daxas outside the U.S.

Shares of Forest Laboratories recently declined 0.2% to $32.35.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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