FDA Advisory Panel Calls Mannkind Diabetes Drug Safe
The FDA's advisory panel voted in favor of backing the inhaled diabetes drug Afrezza produced by Mannkind Corp. The panel said that the treatment for diabetes was safe and effective for patients with either type 1 or type 2 diabetes. The panel voted 13-1 in favor of supporting the rapid-acting insulin treatment for treating patients with type 1 diabetes. The panel also voted 14-0 in support of Afrezza for treating patients with type 2 diabetes — the more prevalent form of the disease.
While the panel voted in favor of this treatment, the FDA can also choose to make an approval decision that does not follow the panel's recommendation. The FDA is expected to decide whether to approve the drug by April 15th. However, the votes for approval are good news for Mannkind, which has been working to get its first product out into the market. Mannkind has spent more than seven years trying to get approval for this treatment, the LA Times says. The FDA rejected the drug in 2011 after Mannkind decided to change its inhalers in the midst of the review process.
There have been questions about Afrezza's effectiveness in treating patients with type 1 diabetes. Some have said that there is not enough data proving Afrezza is more effective than insulin. However, the panel did say that it was more beneficial for adult patients than insulin drugs. Not to mention, there are benefits to patients.
Mannkind has stated that the whistle-sized inhaler treatment is more convenient and less painful than the insulin injections that most diabetics are forced to undergo. Since diabetes can affect eye sight and cause arthritis, some patients find it difficult to properly inject themselves with insulin. The panel agreed that the Mannkind inhaler treatment could provide a satisfactory alternative for those with poor eyesight, arthritis, or even a phobia of needles.
There are still some lingering concerns about the drug, however. In particular, the board expressed concern over some of the potential side effects of the drug — including the possibility that it could be linked to lung cancer. According to the panel's chairman, Robert Smith, Afrezza can be effective, but more research is necessary in order to gain more data about the drug’s effect. “There likely are circumstances under which Afrezza would be effective... but not simply in all patients,” said Smith. “It's very important to follow this up.”