(Adds share price, details from meeting, company comment,
background on drug)
By Susan Heavey
HYATTSVILLE, Md., April 1 U.S. health advisers
on Tuesday recommended approval of MannKind Corp's
inhaled diabetes drug, and said the experimental treatment could
help some patients, especially those wary of needles typically
used with traditional insulin therapy.
The Food and Drug Administration's panel of outside advisers
said that while the therapy, called Afrezza, did not appear as
beneficial for adults with type 1 diabetes, it was clearly safe
and effective for those with the more common type 2 form of the
Overall, it voted 13-1 to recommend approval for patients
with type 1 diabetes and unanimously backed it for those with
type 2, adding that longer-term studies would still be needed to
monitor possible side effects such as lung cancer.
According to the American Diabetes Association, more than 25
million U.S. children and adults have diabetes, a chronic
condition that affects insulin needed for digestion and impacts
blood sugar levels. Just 5 percent of those - mostly children
and young adults - have type 1 diabetes where the body does not
make insulin. The rest have type 2, which is caused as the body
slowly stops responding to insulin and is caused by overeating,
a lack of exercise and other factors.
If left unchecked, complications can include blindness,
kidney failure and other problems.
The panel's recommendation paves the way for final approval
later this month of the whistle-sized device and sent shares of
the company soaring in after-hours trading.
The FDA, which does not have to follow its panel's advice,
is expected to make its approval decision by April 15.
"There is a very important need for new treatment options,"
said panel chairman Robert Smith, an endocrinologist and
professor of medicine at Brown University, adding that the
therapy would not be suitable for all patients.
Overall, the panel of outside advisers agreed with the
drugmaker's argument that the novel inhaler offered a crucial
alternative for many diabetics whose current treatment involves
painful and cumbersome injections.
Panelists said the device could be especially helpful for
type 2 diabetes patients, many of whom are older and may have
problems giving themselves shots because of poor eyesight or
arthritis in their hands. It could also help those who have an
extreme phobia of needles, they said.
Panelists expressed some concerns over data that showed the
drug did not work any better than traditional insulin in
patients with type 1 diabetes, also known as juvenile diabetes.
But having a more convenient insulin option could help some
younger patients manage their disease, they said.
In a statement after the panel's vote, MannKind welcomed the
advisers' support. This is the company's third time seeking
FDA's approval of the drug, which it wants to market as
rapid-acting mealtime insulin therapy.
Shares of the company rose 124 percent to nearly $9 in
after-hours trade on Tuesday on Nasdaq after earlier being
halted pending the outcome of the FDA panel's vote. They closed
at $4.02 on Monday.
The Valencia, California-based drugmaker told the panel its
inhaler delivers more effective, rapid-acting insulin than
injectable products offered by Eli Lilly and Co and
Denmark's Novo Nordisk.
If approved, Afrezza would be the first inhaled insulin
therapy available in the United States since 2006 when the FDA
approved Pfizer Inc's Exubera, a bulk inhaler that was
discontinued by the company after weak sales. Later, data showed
a potential but unproven link between Exubera and lung cancer.
Panelists said the were mindful of Exubera's history as FDA
staff reviewers pointed to four cases of lung cancer found in
patients during MannKind's latest trials.
The advisers said there was not enough data on the potential
cancer risk and called for more long-term study of Afrezza if
the FDA approved the drug.
"I don't think we have enough information to feel confident
that it's not an issue," panelist Eva Szabo, head of lung cancer
prevention research at the National Institutes of Health's
National Cancer Institute. "So the concern remains there."
(Editing by Peter Cooney and Eric Walsh)