April 7 Merck & Co Inc said the U.S.
Food and Drug Administration (FDA) declined an application to
include information on the labels of its diabetes drugs -
Januvia and Janumet - that the treatments do not raise the risk
of major heart problems.
Merck is reviewing the regulator's response to its
application, the company said on Friday.
Some 29 million Americans have diabetes, but even when
glucose levels are under control, the disease greatly increases
the risk of heart disease and stroke, according to the American
Any evidence of heart-protective qualities carried by
diabetes drug labels would therefore serve to boost sales of the
The FDA in December allowed Eli Lilly and Co and
German partner Boehringer Ingelheim to state on labels that
their diabetes drug, Jardiance, reduces the risk of death from
heart problems, potentially improving the drug's future sales.
The decision marked the first time a diabetes treatment was
allowed by the agency to carry a label that said the drug cut
the risk of cardiovascular death.
Jardiance, which belongs to a class of treatments called
SGLT2 inhibitors, raked in nearly $202 million in 2016 sales.
With the updated label, some analysts have predicted
Jardiance will bring $4 billion in sales by 2025.
Merck's Januvia and Janumet generated sales of more than $6
billion last year.
Januvia is an oral medication, known chemically as
sitagliptin, that helps lower blood sugar levels. Janumet is a
related combination product.
Merck had submitted its application to include heart safety
data on the drugs' labels based on a keenly watched study
involving 14,724 patients who had type 2 diabetes and a history
of heart disease.
The study's results, announced in 2015, showed that adding
Januvia to standard care did not increase major heart problems.
Study data also showed no increase in hospitalization rates
for heart failure, which had been a particular concern with
DPP-4 inhibitors, the class of drugs to which Januvia belongs.
The study, which was undertaken after heart safety concerns
were raised over other diabetes medicines, was conducted by an
independent academic research tie-up between the University of
Oxford and Duke University.
Type 2 diabetes, closely linked to obesity, accounts for
more than 90 percent all diabetes cases.
(Reporting by Natalie Grover in Bengaluru; Editing by Sai