It’s been long, hard road for MannKind Corporation (NASDAQ:MNKD) in trying to get its inhaled insulin product Afreeza approved by the Food and Drug Administration, but the company cleared a near-final hurdle in the process yesterday. An FDA advisory committee voted 13-1 that MannKind Corporation (NASDAQ:MNKD)’s Afrezza was safe and effective enough for approval as a treatment for Type 1 diabetes, and 14-0 that was safe and effective enough for approval as a treatment for Type 2 diabetes.
Surprisingly positive vote
The committee vote to endorse the use of Afreeza was not as much of a surprise as the near-unanimous final tally. Analysts point out that FDA scientists made strong criticisms of Afrezza, calling it marginally effective and riskier than alternatives. MannKind Corporation (NASDAQ:MNKD) had already been rejected twice by the FDA in seeking approval for Afreeza, and has had to conduct additional clinical trials to satisfy regulators.
Third Point's Dan Loeb discusses their new positions in a letter to investor reviewed by ValueWalk. Stay tuned for more coverage. Loeb notes some new purchases as follows: Third Point’s investment in Grab is an excellent example of our ability to “lifecycle invest” by being a thought and financial partner from growth capital stages to Read More
The committee did express concerns that long-term exposure to insulin could lead to lung cancer. Lung cancer was more prevalent among those who received Afrezza in clinical trials, but the numbers involved were too small to make a definitive assessment. MannKind Corporation (NASDAQ:MNKD) will likely be required to undertake a long-term study to assess that risk if/when the drug receives final approval for marketing.
Statement from Ad Com committee chairman
Dr. Robert J. Smith, an endocrinologist at the Alpert Medical School at Brown University and the committee’s acting chairman, explained his point of view in an interview after the vote. “As an inhaled form of insulin, this represents a drug that will serve some patients that are not effectively served by currently available insulin.”
Statement from Mannkind founder Alfred E. Mann
Alfred E. Mann, the 88-year-old founder of MannKind Corporation (NASDAQ:MNKD), said in a statement that he was happy with the FDA committee vote. “Diabetes is a major health problem in the United States,” he said, “and we are committed to bring Afrezza to the many patients who might benefit from this novel product.”
The FDA is due to make a decision regarding the approval of Afrezza by the middle of this month. Historically, the FDA has followed the advice of its advisory committees over 90% of the time.
MannKind Corporation (NASDAQ:MNKD) shares were trading close to $8 in the premarket today, up almost 100%.