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BIG PHARMA
NOVO NORDISK’S ORAL
SEMAGLUTIDE MEETS MAIN GOAL
IN PIONEER 6 CARDIOVASCULAR
OUTCOMES TRIAL
Novo Nordisk on Friday reported
results from a Phase IIIa pre-
approval cardiovascular outcomes
trial showing that oral semaglutide,
its experimental GLP-1 analogue
taken once daily, achieved the An injectable version of
primary endpoint of non-inferiority semaglutide, which is dosed
of major adverse cardiovascular once-weekly, is already approved
events (MACE) versus placebo in
patients with type 2 diabetes at high in the US, EU and Canada
risk of cardiovascular events. The
company, whose shares rose as
much as 4.2 percent on the news,
said it expects to file the drug for
regulatory review in the US and EU
in the first half of 2019.
compared with placebo, but there trials, as well as the PIONEER
“We are very encouraged that were no significant differences 4 and PIONEER 7 studies that
PIONEER 6 demonstrated in rates of non-fatal myocardial compared oral semaglutide with
cardiovascular safety, as well as infarction or non-fatal stroke, which its injectable GLP-1 analogue
a significant reduction in both “were broadly similarly distributed Victoza (liraglutide) and with
cardiovascular and all-cause between the two treatment arms.” Merck & Co.’s DPP-IV inhibitor
mortality following oral semaglutide Moreover, a significant reduction in Januvia (sitagliptin).
treatment,” commented chief all-cause mortality of 49 percent in
science officer Mads Krogsgaard favour of oral semaglutide was also An injectable version of
Thomsen. “Based on the strong observed. semaglutide, which is dosed
clinical data reported throughout the once-weekly, is already approved
PIONEER clinical trial programme, In regards to secondary in the US, EU and Canada
we have now established a solid endpoints, Novo Nordisk said under the name Ozempic for the
efficacy and safety profile for oral improvements in HbA1c levels, treatment of adults with type 2
semaglutide,” he added. body weight and blood pressure diabetes. Novo Nordisk stated
were “similar” to results reported that it has been “engaged in a
PIONEER 6 enrolled 3183 adults throughout the PIONEER constructive dialogue” with the
with type 2 diabetes at high risk of programme for oral semaglutide, FDA in a bid to minimise the
cardiovascular events who were while the drug’s safety profile in need for additional separate
randomly assigned to receive PIONEER 6 was “consistent” with large cardiovascular outcomes
oral semaglutide or placebo, both that seen in previous PIONEER trials to obtain a cardiovascular
in addition to standard of care trials. indication for semaglutide in
treatment. Novo Nordisk noted that different formulations. In light of
aside from achieving the main goal Novo Nordisk noted that the latest results, the company is
of non-inferiority, there was also a PIONEER 6 is the last study of the “now evaluating the potential to
21-percent reduction in MACE in PIONEER clinical development obtain a cardiovascular indication
favour of oral semaglutide, although programme, which enrolled a for Ozempic” based on clinical data
this did not reach statistical total of 8845 patients with type from the SUSTAIN 6 cardiovascular
significance. 2 diabetes across 10 trials that outcomes study in combination with
were all completed this year. The PIONEER 6.
The company said oral semaglutide drugmaker previously reported
showed a significant 51-percent positive results from the PIONEER
reduction in cardiovascular death 1, PIONEER 5 and PIONEER 8
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