FDA Delays Decision on MannKind Drug

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The U.S. Food and Drug Administration has informed MannKind Corp. that it can’t meet its own deadline for making a decision on whether it should approve the Valencia biotech’s inhaled insulin drug, the company said late Friday.

The FDA was scheduled to make its ruling by Jan. 16, but told MannKind that inspectors had not yet completed review of the plant that will manufacture the insulin on a contract basis. The facility is operated by N.V. Organon, a subsidiary of Merck Inc.

MannKind also said that it will change the spelling of its brand name for the inhaled insulin therapy from Afresa to Afrezza to avoid confusion with another drug on the market.

Shares of MannKind, which earlier closed down 3 percent to $8.04, fell another 2 percent in after-hours trading.

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