(Updates with company comment, background)
By Toni Clarke
WASHINGTON, June 27 The U.S. Food and Drug
Administration said on Friday it has approved MannKind Corp's
inhaled insulin, Afrezza, capping an arduous journey
for the company and its octogenarian founder, Alfred Mann.
Afrezza is delivered via a whistle-sized inhaler. It acts
more rapidly than injectable insulins such as Eli Lilly and Co's
Humalog and Novo Nordisk's NovoLog.
The FDA said the device offers a new treatment option for
patients with diabetes.
"Today's approval broadens the options available for
delivering mealtime insulin in the overall management of
patients with diabetes who require it to control blood sugar
levels," Dr. Jean-Marc Guettier, director of the FDA's
endocrinology division, said in a statement.
Afrezza will carry a boxed warning, the strongest advisory
available, of the risk of acute bronchospasm, or constriction of
the airways of the lung, in patients with asthma and chronic
obstructive pulmonary disease.
According to the prescribing information, patients with
chronic lung disease such as asthma or chronic obstructive
pulmonary disease should not use Afrezza. Physicians should take
a detailed medical history, physical exam to identify potential
lung disease before prescribing the product.
The label also recommends it not be used in patients who
smoke or who have recently stopped smoking.
The company will also be required to conduct four additional
studies: one to evaluate Afrezza's safety and efficacy in
children; another to assess any potential increased risk for
lung cancer and heart problems; and two to further examine the
way the drug works and is dosed in the body.
MannKind's stock, which was trading down about 10 percent
before news of the approval was announced, pared those losses to
close down 5.5 percent at $10.00 on the Nasdaq Stock Exchange.
In April, an advisory committee to the FDA recommended
approval of the device, though analysts warned at the time that
the company would likely have to conduct additional studies to
demonstrate its safety over the long term. The cost of these
studies could keep potential partners on the sidelines, they
The stock is up 43 percent since the positive advisory
The road to approval has been a tough one for MannKind. The
product was developed in the shadow of Pfizer Inc's
failed inhaled insulin Exubera, which was approved in 2006 and
expected to generate annual sales of $2 billion. But the inhaler
was big and bulky and patients were put off by the need for
periodic lung function tests. Eventually it was withdrawn.
That failure, together with concerns the inhaled powder
could increase the risk of lung cancer, has led to considerable
investor skepticism about Afrezza's future.
In 2011, the FDA rejected the device and asked for more
clinical trials. Despite repeated set-backs, Mann, who is 88 and
the company's biggest shareholder, pumped close to $1 billion of
his own money into the Valencia, California-based company to
keep it afloat.
For Mann, the FDA's decision is a vindication.
"Today's FDA action validates the years of clinical research
and commitment that powered the development of this unique
therapy," he said in a statement, adding that Afrezza "has the
potential to change the way that diabetes is treated."
(Additional reporting by Bill Berkrot in New York; Editing by
Sandra Maler, Bernard Orr)