FDA Rejects Inhaled Insulin Treatment
Federal regulators have rejected a new inhaled insulin treatment from drug maker MannKind. The diabetes treatment was due to have been manufactured in Danbury.
The Food and Drug Administration ruled Wednesday that it needs two more clinical trials before it can once again consider approving Afrezza, an inhaled form of insulin. This means a further delay of at least a year. California-based MannKind had invested in a plant in Danbury to make the treatment once it had permission to bring it to market, and much of the preparation of Afrezza for FDA approval took place at the site.
The company’s shares fell more than 40% on the Nasdaq in after hours trading. Entrepreneur Alfred Mann has invested more than $900 million of his personal fortune into the development of the drug delivery system. It’s the latest setback for this type of insulin treatment. Pfizer dropped development of its version, Exubera, in 2007, having spent $3 billion on the treatment.