FDA Panel Votes Against Approval Of Forest Lung Drug Daxas

A Food and Drug Administration panel voted against approval of a proposed new type of lung drug from Forest Laboratories Inc. (FRX).

The panel voted 5 to 10 against a question that asked if the data submitted by Forest provided "substantial evidence" to support approval of the product, known as Daxas, to treat certain patients with chronic obstructive pulmonary disease, or COPD

The decision came after two previous votes on Daxas, also known by its generic name, roflumilast, on safety and effectiveness. The panel voted 9 to 6 on each vote that Daxas was effective and safe. The FDA usually follows the advice of its panels but isn't required to do so.

However, some panel members said more information is needed about how Daxas compares to other treatments for COPD before the product is approved.

In a review of the product, the FDA said the effectiveness of Daxas 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 also raised concerns about weight loss seen in some patients taking Daxas.

"Of significant concern are the occurrence of three completed suicides and two suicide attempts" among patients receiving Daxas compared with no suicides or attempts in the placebo group, the FDA said.

The agency said that while clinical studies looking at Daxas showed there was a statistically significant improvement in a measure of lung function compared with groups of patients not taking the drug, "the differences between the groups in mean change from baseline were quite modest."

The product is designed to treat 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 May 2024 to Jun 2024