Forest Labs plunges as FDA panel gives thumbs down to Daxas; and agency clears generic Hyzaar/Cozaar for Teva and NuLytely for Mylan

US drugmaker Forest Laboratories saw its share drop 8.7%, to $29.63 in late trading yesterday, after reports from Reuters and other news services that a Food and Drug Administration panel of external experts had voted against approval of its new drug Daxas (roflumilast). The drug was licensed for US development from Swiss pharmaceutical firm Nycomed in a deal which included an upfront payment of $100 million, plus milestones and royalties (The Pharma Letter August 11, 2009).

The panel voted five to 10 against a question that asked if the data submitted by Forest provided "substantial evidence" to support approval of Daxas to treat certain patients with chronic obstructive pulmonary disease (COPD). The decision came after two previous votes on Daxas relating to safety and effectiveness. The panel voted nine to six on each vote that the drug was effective and safe. 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 panel 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 the drug.