The committee discussed a new drug application for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapy.

A narrow majority of the committee, nine of 16 members, voted that the benefit-risk profile is adequate to support approval for the proposed use. Seven of 16 members voted that the benefit-risk profile is not adequate to support approval for the proposed use.

The committee also voted separately on the adequacy of the efficacy and the safety data.

A majority of the committee, ten of 16 members, voted that the data provide substantial evidence of efficacy for inhaled mannitol for the proposed use. Six members voted that the data do not provide substantial evidence of efficacy for the proposed use.

The same majority of the committee member, ten of 16 members, voted that the safety data are adequate to support approval for the proposed use. Six members voted that the safety data are not adequate for the proposed use.