trending Market Intelligence /marketintelligence/en/news-insights/trending/8OwQJF3g2WQWU7YOwkNjyw2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

Novo seeks US FDA approval for oral diabetes treatment in 2 indications

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

Novo seeks US FDA approval for oral diabetes treatment in 2 indications

Novo Nordisk A/S submitted two new drug applications with the Food and Drug Administration for the oral version of its type 2 diabetes medicine semaglutide along with a supplemental new drug application for its other diabetes medicine Ozempic.

SNL Image

The company's application for oral semaglutide is supported by results from 10 clinical trials conducted under a global program called Pioneer. Novo's oral semaglutide worked better than Merck & Co. Inc.'s Januvia, or sitagliptin, in reducing blood sugar levels in one of the studies, called Pioneer 3.

The Denmark-based pharmaceutical company has used a priority review voucher for the application and expects a decision by the FDA in six months after the submission. The FDA normally takes 10 months to decide on an application.

Novo is also seeking approval from the US regulator to market oral semaglutide to reduce cardiovascular risk in adult patients with type 2 diabetes. The application is based on results from the Pioneer 6 trial, in which oral semaglutide was added on top of standard of care therapy to determine its effectiveness against placebo.

Novo also submitted a supplemental drug application for a weekly dose of Ozempic, an injectable version of semaglutide, to reduce cardiovascular risk in adult patients with type 2 diabetes. The company's application is based on results from a phase 3 trial called Sustain 6 in which Ozempic reduced the risk of major adverse heart events by 21% compared to placebo.

The FDA approved Ozempic for adults with type 2 diabetes in December 2017.

The two applications for Ozempic and semaglutide to treat patients at the risk of cardiovascular events will be reviewed under the FDA's standard period of 10 months.