FDA Delays MannKind Corporation’s Inhaled Insulin Afrezza Approval

To have more time for a full review, the U.S. Food and Drug Administration delayed the review period of MannKind Corporation's inhaled insulin Afrezza by three months. Now, the review will be carried out on July 15.

Before pushing back the date, the MannKind's hearing with the FDA committee was scheduled for April 15. But it has been found that the company has submitted more information to get green signal for the drug, which has led the FDA to extend the review period.

It was last week only when an advisory panel to the FDA suggested approval of Afrezza. The powder is said to be quiet effective as inhalation of powder delivers insulin to the bloodstream within 12 to 15 minutes in comparison to 90 to 150 minutes required for insulin injections.

In the voting, the drug was able to get 13 to 1 vote for type- 1-diabetes and 14 to 0 votes for type-2- diabetes. But there were some members of the panel who expressed concerns with regard to possible side effects.

After the news got publicized, the shares of the company witnessed a minor drop in its shares. Its shares were down nearly 11% amounting to $6.13. "We view an approval [of Afrezza] as the most likely outcome, given the overwhelmingly positive vote, but continue to see some risk in the decision", affirmed Cowen & Co. analyst Simos Simeonidis.

If the drug gets approved then it would be required to be taken before a meal and will let diabetics to get freedom from pricking needles to inject insulin. The drug has been rejected a couple of times before by the FDA due to efficacy and safety issues.


AustrianTribune Specials

Guests on a cruise sponsored by Chicago's Shedd Aquarium and Un-Cruise Adventures got to rare chance to feast their eyes on two oarfish in the shallow waters along the coastline of Baja, Mexico.

A video of the sea creatures posted on...

Most Popular

A 10-year study by researchers from Arizona State...

The discovery of 520-million-year old three-inch-long...

Eleven cases of potentially deadly Middle East...

This year's NASA annual International Space Apps...

Automotive News

  • Nearly nine hundred thousand Honda Odyssey minivans recalled
  • Disgruntled Workers Burn Tires to Block Two Managers in Goodyear Factory

UK News

  • Researchers discover cardiovascular system in oldest shrimp fossil known to date
  • Genetic Similarities between Humans and Neanderthals are Result of Interbreeding
  • Smog-Like Conditions Expected to Remain in UK until Friday
  • 2013 recorded Highest Level of Litter on British Beaches in Two Decades
  • Unjustified Suspicion of Statins is Costing Lives, says Britain’s Senior Doctor