MannKind, United Therapeutics Jump as Inhaler Gets FDA Nod (3)

(Updates to add Jefferies commentary and closing pricing.)

MannKind and United Therapeutics both surge after the FDA approved their Tyvaso DPI product for lung disease.

• The FDA says that the inhaler’s potential pulmonary risks “are adequately characterized” by available data and addressed in the product’s label
  • FDA said it was approved to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease in a letter rejecting a Citizen’s Petition requesting the agency not to approve the inhaler combo
  • The agency “determined that the available data are sufficienttx! to evaluate Tyvaso DPI’s potential pulmonary risks, including the risk of ...