FDA Panel: Forest Lung Drug Daxas Appears Effective

A Food and Drug Administration panel said Wednesday that a proposed new type of lung drug from Forest Laboratories Inc. (FRX) appeared to be effective.

The panel voted 9-to-6 that the proposed drug, roflumilast, was effective at treating patients with chronic obstructive pulmonary disease who have chronic bronchitis.

While the panel is scheduled to vote later Wednesday on whether it thinks roflumilast should be approved, the vote on effectiveness is important as the FDA said it thought the product's effectiveness was "quite modest." However, during discussions of the product, some panel members said they were concerned about side-effects of the drug so it is not clear how the panel will vote on the approval question.

The FDA usually follows the advice of its panels of outside medical experts but is not required to.

If approved, roflumilast would be sold under the brand name Daxas.

The product is designed to treat chronic obstructive pulmonary disease, or COPD, which 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 is the fourth-leading cause of death in the U.S.

Daxas, a tablet that would be taken once daily, works by inhibiting an enzyme called phosphodiesterase 4, which is believed to play a role in the inflammatory process involved with airway constriction. It would fall into a category of drugs known as PDE-4 inhibitors.

So far, companies have struggled to develop PDE-4 inhibitor products. In 2003, an FDA panel voted against approval of a similar drug, cilomilast, which was being developed by GlaxoSmithKline PLC (GSK).

Another company, Nycomed, submitted the Daxas application to the FDA last July, but the application was transferred to Forest in December, according to the FDA. The FDA said Forest amended the application and proposed a narrower indication for the product as well as a warning regarding neuropsychiatric events.

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

Forest Road Acquisition (NYSE:FRX)
Historical Stock Chart
From Jun 2024 to Jul 2024