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 Shares in Novo Nordisk rose almost 3 percent in early trading on
Thursday, after the panel late on Wednesday concluded semaglutide is
effective, reasonably safe and should be approved by the FDA.
The panel voted 16-0 with one abstention in favor of the drug being
approved. It would compete with others in a class known as glucagon-like
peptide-1 (GLP-1) analogs, which imitate an intestinal hormone that
stimulates the production of insulin.
The FDA, due to decide on the drug by Dec. 5, typically follows the
recommendations of its advisors.
"This should pave the way for a timely approval," Chief Scientific
Officer Mads Krogsgaard Thomsen said in an interview.
Novo Nordisk expects semaglutide, administered through a once-weekly
injection, will take market share from Eli Lilly's once-weekly
Trulicity, which in turn has been taking share from Novo Nordisk's
once-daily Victoza.
"When you have the best (drug), if you cannot win market share, you
should do be doing something other than supplying medicine to
people," said Thomsen.
Novo will also target some 95 percent of the around 30 million
diabetics in the United States who currently don't use GLP-1 drugs,
he said.
PRICE RANGE
Novo plans to price semaglutide, which has yet to get a brand name,
in a similar range as existing GLP-1 drugs, possibly with a small
premium, Thomsen said, adding Novo Nordisk is also developing an
oral form of semaglutide that it aims to launch in 2020.
Analysts on average expect annual semaglutide sales to reach $3.17
billion by 2023, with sales of Trulicity, which was approved in the
United States in late-2014, rising to $3.71 in 2023, according to
Thomson Reuters data.
"We believe semaglutide will be a formidable competitor for Lilly's
Trulicity," Alex Arfaei, an analyst at BMO Capital Markets, said in
a research note.
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Panelists discussed data showing semaglutide was associated with an
initial worsening of diabetic retinopathy, a condition caused by
damage to blood vessels in the retina due to high blood sugar
levels. The damage can cause progressive deterioration in vision,
potentially leading to blindness.
But they found that the benefit of reducing blood sugar overall
offset this risk, which the company argues is transient. Thomsen
said most panel members supported Novo's ambition that the drug's
label will to carry a standard warning, similar to insulins,
regarding diabetic retinopathy. The FDA will decide on the final
label.
The drug has also been shown to reduce cardiovascular risks,
although it was unclear whether the FDA will include that in the
label.
Most panel members pointed to the need of a larger post-approval
study of the drug, a study that will be initiated next year, Thomsen
said, without giving further details on the scope of the study.
(Reporting by Toni Clarke; Additional reporting by Stine Jacobson in
Denmark; Editing by Richard Chang and David Holmes)
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