News on Wellness

MannKind Shares Drops As FDA Delays Afrezza Drug’s Approval

FDA

Shares of MannKind corporation dropped today after US Food and Drug Administration (FDA) delayed approval of inhaled insulin Afrezza even though the advisory panel of the agency recommended for approval on Wednesday.

Schaeffer’s Investment Research says the shares have plopped 8 percent and it closed at $6.32.
FDA
The approval was scheduled for April 15, but now it has been pushed to July 15, about three months from now, to allow more time to FDA for a complete review of the recent information submitted by MannKind.

On Wednesday the drug Afrezza garnered a 13 to 1 vote for type I diabetes and for the type 2 diabetes the vote was 14 to 0.

The new drug Afrezza will be a good replacement to the injecting insulin for diabetes patients. It is made to be inhaled before a meal and insulin gets absorbed into the blood stream via the lungs’ alveoli and it reaches to peak in just 12 to 15 minutes. The injecting insulin takes between 45 to 90 minutes of administration.

Several times earlier FDA rejected Afrezza questioning its safety and efficacy.

First time when the drugmaker presented the drug, FDA questioned its effects among patients suffering with pulmonary dysfunction, lung and renal diseases. The committee was also concerned for people with asthma and bronchial spasms. Also, the accuracy of the dosage and its amount were questioned. The shares then, on March 28, dropped to $5.03.

Approval of the new drug would benefit more than 26 million diabetics in the US.

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