FDA Reviewers Interrogated Forest Laboratories Inc, Nycomed for Daxas’ Effectiveness
FDA Reviewers Interrogated Forest Laboratories Inc, Nycomed for Daxas’ Effective

The effectiveness of a proposed lung drug from Forest Laboratories Inc and Nycomed was interrogated by the U. S. drug reviewers on Monday.

Forest shares declined 1.4% to hit $30.99, in afternoon trading on the New York Stock Exchange. It shed about 3.8% in the early period of this session.

Patients with chronic obstructive pulmonary disease, who were given Daxas, were improved in lung function, but quite modestly, according to the Food and Drug Administration reviewers. Problems which are associated to Daxas' class of drugs include nausea, diarrhea and weight loss.

The FDA staff shared, in a summary prepared for an advisory panel that the occurrence of three completed suicides and two suicide attempts are of important concern. The panel will be reviewing the drug on Wednesday.

Nycomed, a privately held Swiss drug maker, originally developed the drug. As Daxas is needed for new COPD treatments, Lazard Capital Markets analyst Bill Tanner opined that any of these concerns would not disrupt the approval of Daxas.

Bill said, "I think it's approvable. Clearly there's an unmet medical need. This is doing something that other COPD drugs don't. We're pretty comfortable thinking it's probably a $500 million drug and it gets approved".

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