Shares of MannKind Corp. (MNKD) plunged by as much as 20% at one point during Friday’s trading session after the US Food and Drug Administration [FDA] said the company’s newly approved inhalable diabetes drug “Afrezza” isn’t a substitute for long-term insulin use and must be used with long-acting insulin in patients with type 1 diabetes.
The FDA, whose Afrezza approval came with a boxed warning, the strongest advisory available, stated that it wants the company to remain in close contact with physicians to see how the drug is performing, and is requiring more post-marketing trials for treating children and assessment of possible pulmonary cancer risks. The FDA also warned that the drug, which is designed to be used at the beginning of a meal or within 20 minutes after the start of a meal in order for it to work, should not be used in patients with chronic lung diseases, such as asthma, due to reports of breathing spasms.
FDA approval for a new drug is usually a cause for celebration, but that wasn’t the case Friday for MannKind Corp. investors who saw their shares close down nearly 6 percent, to $10.00 on the Nasdaq Stock Exchange.
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