Afrezza hopes that its inhalable insulin product will be a gamechanger for diabetics. (Image courtesy Afrezza).
Insulin injections may soon be a thing of the past if Mannkind Corp.'s inhalable insulin product, Afrezza, is approved by FDA—assuming it finds a wider user base than Pfizer's Exubera inhaled insulin, which it yanked from the market in 2007.
Mannkind's drug-and-inhaler combination device has received the go-ahead from FDA's Endocrinologic and Metabolic Drugs Advisory Committee. Then FDA extended the Prescription Drug User Fee Act (PDUFA) date for the product by three months to July 15, 2014. This, Mannkind said in a press release, is to provide FDA with the time to conduct a "full review" of documents the company submitted in response to FDA requests.
In its vote, the advisory committee recommended 13 to 1 that Afrezza be approved for type 1 diabetics to improve glycemic control in adults. For those with type 2 diabetes, the vote was 14 to 0 in favor of granting marketing approval to improve glycemic control in adults. FDA is not bound by the Advisory Committee's recommendation, but will consider its guidance in reviewing Afrezza's New Drug Application (NDA).
Still, FDA recently announced that it was pushing back the final review date for Afrezza by three months, causing the company's stock to slide on Monday.
"As an inhaled form of insulin, this represents a drug that will serve some patients that are not effectively served by currently available insulin," Robert J. Smith, MD, an endocrinologist at the Alpert Medical School at Brown University and the committee's acting chairman, said after the vote, reported the New York Times.
However, in the Times' article, Andrew Pollack wrote that "The votes were a bit of a surprise because FDA's own staff had been critical in its review of Afrezza, calling it marginally effective and possibly risky. Also, MannKind had failed twice before in trying to win FDA approval, requiring new clinical trials."
Writing for Barron's, Ben Levisohn quoted Cowen's Simos Simeonidis and Yatin Suneja, who said, "We expect that despite the serious concerns raised by the panel, including about Afrezza's safety and efficacy, the agency is highly likely to approve it. After attending the panel last week, we came out with the view that the agency wants to make Afrezza available to patients, in great part because of what is viewed as a "real need" for specific patient groups that may not be good candidates for injectable insulins, like patients not willing or able to use injectable insulins due to poor eyesight, lack of manual dexterity, being alone in their homes without a caregiver, needle-phobia etc…"
According to Mannkind, Afrezza "is a novel, ultra rapid-acting mealtime insulin therapy." It is intended to improve glycemic control in adults with type 1 or type 2 diabetes. The drug-device combination product consists of Afrezza Inhalation Powder that is delivered using a small inhaler.
Mannkind's literature states that Afrezza should be administered at the start of a meal. The Afrezza powder "dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. Peak insulin levels are achieved within 12 to 15 minutes of administration," the company's description continues, "compared to 45–90 minutes for injected rapid acting insulin analogs and 90–150 minutes for injected regular human insulin."