FDA approves MannKind's inhaled insulin
FDA approved a resubmitted NDA for Afrezza from MannKind Corp. (NASDAQ:MNKD) to improve glycemic control in Type I and II diabetics. Afrezza has a boxed warning on the risk of acute bronchospasm in patients with asthma and chronic obstructive pulmonary disease (COPD) and was approved with a REMS comprising a communication plan to inform doctors of the risks. Afrezza must be used in combination with long-acting insulin in Type I diabetics. MannKind is required to conduct four postapproval studies: a pediatric trial, a trial evaluating the risk of pulmonary malignancy and two pharmacokinetic/pharmacodynamic trials. The company does not have a sales force and said it plans to find a pharma commercialization partner for Afrezza "as quickly as possible."
MannKind jumped $2.97 (74%) to $6.99 on April 2 after FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted that Afrezza, a dry powder formulation of insulin plus an inhaler, is safe and effective in the indication (see BioCentury Extra, April 1). ...