The FDA posted documents today saying the effectiveness of Forest Laboratories’ experimental lung drug Daxas was “quite modest” while expressing concern about side effects seen in clinical trials.
In particular, the FDA staff cited three suicides and two suicide attempts among patients using the drug who were studied. Here’s the Dow Jones article.
Despite the low efficacy and pscyhiatric side effects, many analysts think the drug has a good chance to win approval. A committee of outside experts is scheduled to meet Wednesday and review roflumilast, as Daxas is known. The panel will give its thoughts to the FDA, which will make the final decision.
The once-daily pill aims to chronic obstructive pulmonary disease, a nasty condition — often caused by smoking — that makes breathing difficult. There’s no cure available for the ailment, a big plus for the potential treatment aimed at a largely unmet need like COPD, analysts say.
It also helps Daxas’ cause, analysts point out, that Forest Labs took a number of steps to minimize the risks. The company recently narrowed the indication it was requesting to the treatment of flare-ups, rather than more frequent use to treat symptoms. It also said it would warn about the psychiatric side effects in the drug’s label. And it agreed to closely monitor patients taking Daxas for signs of trouble.
Approval would be a big victory for Forest Labs, which licensed the compound last August. Yearly sales could reach as much as $2 billion, says Jefferies & Co. analyst Corey Davis.