Friday, September 29, 2017 2:22:40 PM
Bagsværd, Denmark, 29 September 2017 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved Fiasp ® (fast-acting insulin aspart), a new fast-acting mealtime insulin, for the treatment of adults with diabetes. The FDA’s decision comes after Fiasp ® in clinical trials demonstrated benefits for people in need of improved overall glucose control.
Fiasp ® is an innovative formulation of insulin aspart (NovoLog ® ) developed with the aim of obtaining pharmacokinetic and pharmacodynamic properties that more closely match the natural physiological insulin mealtime response of a person without diabetes.
In clinical trials Fiasp ® has demonstrated clinically relevant improvement in long-term glucose level (HbA 1c ). These results were achieved with a comparable overall rate of severe or blood-sugar confirmed hypoglycaemia, between Fiasp ® and insulin aspart.
“We are very pleased that Fiasp ® will now also be available to people with diabetes in the US,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The fast action profile of Fiasp ® allows people with diabetes convenient timing in terms of when to take their insulin in connection with meals to achieve the optimal blood sugar control.”
About Fiasp ®
Fiasp ® is insulin aspart in an innovative formulation, in which two excipients have been added: Vitamin B3 (niacinamide) to increase the speed of absorption and a naturally occurring amino acid (L-Arginine) for stability. The review of Fiasp ® was based on the ‘onset’ programme, a phase 3 clinical programme comprising four trials encompassing more than 2,100 people with type 1 and type 2 diabetes.
Recent NVO News
- Meta Strengthens Child Privacy on Instagram; Google Overturns $1.7 Billion Antitrust Fine; Snap Updates Spectacles • IH Market News • 09/18/2024 10:13:07 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/16/2024 05:27:43 PM
- GameStop plunges 11% on stock offering, DJT drops post-debate, GSK fails shingles vaccine trial • IH Market News • 09/11/2024 10:25:41 AM
- IBM Closes China Research Division, Uber Fined $324M, Starliner to Return Without Astronauts • IH Market News • 08/26/2024 12:58:21 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/14/2024 12:28:58 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2024 08:17:50 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/09/2024 10:00:09 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/07/2024 10:51:12 AM
- US Index Futures Rise Amid Earnings Season Optimism, Oil Prices Rebound • IH Market News • 08/07/2024 09:49:12 AM
- Novo Nordisk Adjusts Outlook, Airbnb Drops 16% on Declining U.S. Demand, Lumen Technologies Surges 48% in Premarket • IH Market News • 08/07/2024 09:42:51 AM
- Google Faces Antitrust Ruling; SunPower Files for Bankruptcy and Business Sale – Latest Business News • IH Market News • 08/06/2024 09:44:42 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/29/2024 11:48:57 AM
- Johnson Controls Division Sold for $8 Billion; Alphabet’s Offer Rejected by Wiz; AMD President Announces Retirement • IH Market News • 07/23/2024 10:00:52 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/22/2024 03:13:08 PM
- Match Group Soars 8% Amid Potential Sale Pressure; Deutsche Bank Anticipates 2Q Loss, and More • IH Market News • 07/16/2024 10:10:09 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/15/2024 12:19:34 PM
- Ericsson Reports 14% Profit Increase, UBS Downgrades Tesla Shares, Ozempic Linked to Reduced Dementia Risk • IH Market News • 07/12/2024 10:28:11 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/11/2024 10:00:09 AM
- Microsoft and Apple Exit OpenAI Board, TSMC Exceeds Forecasts with Record Revenue, and Other Key Updates • IH Market News • 07/10/2024 10:42:17 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 07/09/2024 01:49:47 PM
- Paramount-Skydance $28B Merger, Boeing Agrees to Plead Guilty with $243.6M Fine, and More News • IH Market News • 07/08/2024 10:37:52 AM
- Tesla Listed for China’s Government Vehicles; Macy’s Acquisition Offer Raised, and More News • IH Market News • 07/05/2024 12:13:34 PM
- Nike Stock Drops 14% in Pre-Market; Nokia Acquires Infinera for $2.3 Billion, and More News • IH Market News • 06/28/2024 10:50:25 AM
- Interactive Brokers Loses $48 Million on NYSE, Amazon Achieves Historic Market Value, and More News • IH Market News • 06/27/2024 11:13:41 AM
- SolarEdge Stock Falls 13%, Wegovy Approved in China, Grail Nasdaq Debut, Apple Rejects Meta Chatbot • IH Market News • 06/25/2024 10:36:11 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM