May 24 (Reuters) - Advisers to the U.S. health regulator
on Friday voted against the use of Novo Nordisk's
weekly insulin in patients with type 1 diabetes due to risks of
low blood sugar.
The Food and Drug Administration's panel of independent
experts voted 7-to-4, saying the weekly insulin icodec's
benefits do not outweigh the risks
Novo is aiming to be the first to hit the market with a
weekly insulin product, offering an alternative for patients
with type 1 and type 2 diabetes who now depend on multiple daily
injections.
"I'm concerned that approving (insulin) icodec for use at
this point with inadequate data might be a disincentive for
further trials, which I think are needed in order to use it
safely in type one diabetics," said Cecilia Low Wang, the panel
chairperson.
The comments come after the FDA's staff on Wednesday flagged
the risk of low blood sugar in type 1 diabetes patients, who are
more insulin-dependent, and the lack of clinical data to support
Novo's proposed methods for mitigating the risks associated with
hypoglycemia, a condition in which blood sugar levels drop below
the standard range.
Novo said it will continue to work closely with the FDA to
identify the next steps needed to bring the treatment to market.
The increase of hypoglycemic events for type 1
diabetics, could prove a barrier for these patients, Derren
Nathan, analyst at Hargreaves Lansdown said ahead of the panel
meeting.
Barclays analyst Emily Field said it was plausible for
the FDA to not recommend approval in type 1 patients, but that
Novo could still seek approval for type 2 patients, which is a
larger market.
While the FDA usually follows the recommendations of its
expert panel, it is not obligated to do so.
The weekly basal injection, under the brand name Awiqli, was
approved earlier this week for use in the European Union, the
Danish drugmaker said on Friday.
Basal insulin helps regulate blood glucose levels throughout
the day compared to bolus insulin which manages blood glucose
rise after meals.
Rival Eli Lilly ( LLY ) is also developing its own
once-weekly insulin injection, efsitora.