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MannKind says inhaler is on track for approval

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Bloomberg News

MannKind Corp., the company staking its future on inhaled insulin, said Thursday that its drug didn’t cause adverse lung effects in the last studies for U.S. regulatory approval.

MannKind shares rose 18 cents, or 6.2%, to $2.91 after the announcement. The Valencia-based company said its Afresa inhaler met its primary goals in its last two human trials. The company expects to apply early next year for Food and Drug Administration approval to sell Afresa, said Peter Richardson, MannKind’s chief scientific officer.

MannKind has said its inhaled insulin is better than similar products abandoned by other drug makers because of unwieldy inhalers and the risk of lung cancer. MannKind, which has no products on the market, has predicted Afresa sales could top $1 billion a year.

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Two years of tests on more than 2,000 people with Type 1 or Type 2 diabetes showed “no adverse effects on patients’ lungs,” MannKind said.

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