*
Orforglipron maintains weight loss after switching from
injectable GLP-1 drugs
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Lilly and Novo Nordisk await U.S. regulatory approvals for
weight-loss pills
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FDA may expedite review of Lilly's orforglipron
(Adds analyst comment in paragraph 6, investor comment in
paragraph 8)
By Christy Santhosh and Sneha S K
Dec 18 (Reuters) - Eli Lilly's ( LLY ) oral pill helped
maintain weight loss in patients switching from injectable
versions of GLP-1 drugs, the company said on Thursday, in a
boost to deliver a more convenient obesity treatment option.
An oral weight-loss pill would help Lilly further widen its
lead over close rival Novo Nordisk and strengthen its
position in a market that is expected to see several new
entrants.
Both Lilly and Novo are awaiting U.S. regulatory approvals
for their pills, with a decision on Novo's oral Wegovy expected
at the end of December and Lilly's orforglipron early next year.
In the late-stage trial, patients who took orforglipron for
52 weeks, after an initial treatment period of 72 weeks with
Wegovy or Zepbound, showed superior weight maintenance compared
to those on placebo, Lilly said.
Patients who switched from Wegovy maintained their
previously achieved weight loss with an average difference of
0.9 kilograms (kg), while those who switched from Zepbound
maintained it with an average difference of 5 kg.
"An 80-95% maintenance of weight loss certainly would look
good in marketing materials. This now confirms that orforglipron
can be a great option for de-escalating treatment and improving
convenience for chronic weight maintenance," Bernstein analyst
Courtney Breen said.
The most commonly reported side effects were mild to
moderate and gastrointestinal, consistent with previous studies
on orforglipron.
"Lilly has had an excellent recent run and we would not
categorize this clinical trial as pivotal however strong the
results are this morning," said Kevin Gade, chief operating
officer at Bahl and Gaynor, which holds Lilly shares.
Lilly's pill helped patients lose 12.4% of their body weight
in a late-stage study. In a separate trial, Novo's pill led to a
16.6% reduction in weight.
Lilly was granted a fast-track voucher for its pill in
November as part of a deal with the Trump administration to
lower the prices of its weight-loss medicines for government
programs and cash-paying patients.
According to a Reuters report, leaders at the U.S. Food and
Drug Administration have pressed internally for reviewers to
speed up their evaluation of orforglipron, after the company
pushed for a faster timeline.
The agency could decide on Lilly's pill as early as March 28
if the new timeline is adopted.
(Reporting by Christy Santhosh and Sneha S K in Bengaluru;
Editing by Anil D'Silva)