Newsroom – Published in AJMC on: March 21,
Novo Nordisk Seeks Oral Semaglutide Approval, CV Indications on New Drug and Injectable
Mary Caffrey and Samantha DiGrande
If approved the oral form of semaglutide would be the first pill in the
GLP-1 receptor agonist class.
Novo Nordisk today filed for FDA approval
of oral semaglutide, which would be the first glucagon-like peptide-1 (GLP-1)
receptor agonist in a pill form. The drug maker also filed for a new
cardiovascular (CV) indication for its once-a-week injectable form of
semaglutide, which the FDA approved in December 2017. The weekly injectable
GLP-1 receptor agonist is sold as Ozempic. The company announced the filings in
For oral semaglutide, the drug maker
submitted 2 New Drug Applications (NDAs): the first seeks approval to control
blood glucose to treat type 2 diabetes (T2D) through a priority review process
that would take 6 months. A second NDA was filed seeking an indication to
reduce major adverse CV events, such as heart attacks, strokes, and CV death,
in adults with T2D and established CV disease; that review is expected to take
The filings are based on the PIONEER
clinical trial program for oral semaglutide, which included a cardiovascular
outcomes trial (CVOT), and SUSTAIN 6, a CVOT for the once-weekly injectable
semaglutide. Unlike the injectable form, the oral form of semaglutide would be
taken once a day.
"We are very excited about these three
regulatory filings with the FDA as they represent a significant milestone for
the company, but most importantly represent new potential treatment options for
adults living with type 2 diabetes," Todd Hobbs, MD, vice president and US
chief medical officer of Novo Nordisk, said in the company’s statement.
"We know that many adults with type 2 diabetes are still struggling to
control their blood sugar and are at increased cardiovascular risk. We hope
that, if approved, these products can help those patients."
Novo Nordisk’s filings come as both the
American College of Cardiology (ACC) and the American Diabetes Association have
endorsed the use of GLP-1 receptor agonist class in clinical guidelines for
patients with T2D and atherosclerotic CV disease. During last weekend’s ACC's
68th Annual Scientific Session in New Orleans, Louisiana, the ACC and the
American Heart Association went a step further and said GLP-1 receptor agonists
and sodium glucose co-transporter 2 (SGLT2) inhibitors may be used in primary
prevention, following results from CVOTs that suggest these classes can prevent
long-term complications from heart failure.
Oral semaglutide could address an unmet
need in patients with T2D and CV risk who are overweight, as the GLP-1 receptor
agonist class has been shown to help patients achieve significant weight loss.
However, not all patients are willing to use an injectable drug, even one only
needed once a week.
An ACC panel discussion reviewed case
studies on when to prescribe GLP-1 receptor agonists or SGLT2 inhibitors, and
cardiologists said there are cases in which GLP-1 receptor agonists are
indicated, but patients will not take an injectable drug. In one scenario
described during the ACC session, an obese female patient was prescribed an
SGLT2 inhibitor instead, but the physician commented that while this would
control her blood sugar, it would not provide the same weight loss benefits.
Hobbs told The American Journal of Managed
Care® in an interview that oral semaglutide was developed with these patients
in mind. “One of the reasons we for many years have tried to develop an oral
GLP-1 is because the injection is still a barrier,” he said. “With patients,
that’s significant, but it’s also significant with many primary care providers.
Our hope and expectation is that we will be able to see more individuals
benefit from GLP-1s in diabetes, and also in primary care in particular.”
Asked to comment on the importance of the
endorsements of the GLP-1 receptor agonist class in recent guidelines updates,
Hobbs said, “The impact of the guidelines is important, no matter the outcome
of the regulatory decision is around the labeling round CV improvement.”
He noted that the recent ACC Expert Consensus Decision
Pathway singled out Novo Nordisk’s liraglutide (Victoza) among the GLP-1
receptor agonist class. This injectable T2D therapy is taken once a day and has
previously received an indication to reduce the risk of CV death.