Wednesday, August 26, 2015 12:04:22 PM
Novo pulls blockbuster diabetes med Victoza off the Type 1 track
By Tracy Staton
Sorry, Victoza. Novo Nordisk ($NVO) has given up on the GLP-1 drug as a treatment for Type 1 diabetes, at least for now. A blockbuster in the Type 2 form of the disease, Victoza fell short in a new late-stage trial as an add-on to insulin therapy.
Higher doses of the drug did cut blood sugar levels and helped patients lose weight, but they also boosted the risk of hypoglycemia, Novo said. The lowest dose failed to beat placebo at controlling blood sugar or triggering weight loss.
Together with the results of a previous Type 1 trial, the latest data underwhelmed Novo execs. The company "does currently not intend to submit an application to expand the label of Victoza for use in type 1 diabetes," Novo said in a statement.
Novo's Mads Krogsgaard Thomsen
"We are disappointed as we believed in the potential to provide people with type 1 diabetes with a new treatment option, and we will continue to invest in new treatment options for this group of people," said Mads Krogsgaard Thomsen, Novo's EVP and chief science officer.
The company will dig around in the clinical data, analyzing it for potential avenues for future study or regulatory moves.
Novo markets insulins commonly used to treat Type 1 diabetes, an autoimmune disorder that is typically diagnosed in childhood, and has been testing Victoza for years as a potential add-on therapy. Phase II trials had been successful enough to prompt the late-stage studies.
In Type 2, Victoza is typically adopted before insulin, as an add-on to the standard therapy metformin. Despite new competition in the GLP-1 field this year, Victoza brought in about $1.3 billion for the first half, up 22% ex-currency effects. And Novo has had success expanding the franchise in other areas. The active ingredient, liraglutide, recently won FDA approval as a weight-loss drug under the brand name Saxenda. A combo version of the med, pairing liraglutide with Novo's new insulin, Tresiba, recently won approval in Europe.
-
Recent MNKD News
- MannKind Receives U.S. FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease • GlobeNewswire Inc. • 05/06/2024 10:05:00 AM
- MannKind Corporation to Hold 2024 First Quarter Financial Results Conference Call on May 8, 2024 • GlobeNewswire Inc. • 05/01/2024 08:00:00 PM
- MannKind to Proceed With Phase 1 Nintedanib Dpi (Mnkd-201) Study for Pulmonary Fibrotic Diseases • GlobeNewswire Inc. • 04/30/2024 10:05:00 AM
- MannKind Announces IND Clearance From U.S. FDA to Start Phase 3 Study of Clofazimine Inhalation Suspension for Nontuberculous Mycobacterial (NTM) Lung Disease • GlobeNewswire Inc. • 04/29/2024 10:05:00 AM
- MannKind Repays Certain Debt Obligations • GlobeNewswire Inc. • 04/03/2024 10:00:00 AM
- MannKind Announces CFO Transition • GlobeNewswire Inc. • 03/26/2024 08:05:00 PM
- INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps • GlobeNewswire Inc. • 03/11/2024 10:05:00 AM
- MannKind Announces New Clinical Data From Inhale-3 Study to be Presented by Dr. Irl B. Hirsch at ATTD on March 8 • GlobeNewswire Inc. • 03/05/2024 11:05:00 AM
- MannKind Corporation Announces Participation at Upcoming Conferences • GlobeNewswire Inc. • 03/04/2024 06:01:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/27/2024 09:05:20 PM
- MannKind Corporation Reports 2023 Fourth Quarter and Full Year Financial Results: Provides Clinical Development Update • GlobeNewswire Inc. • 02/27/2024 09:00:00 PM
- MannKind Corporation to Hold 2023 Fourth Quarter and Full Year Financial Results Conference Call on February 27, 2024 • GlobeNewswire Inc. • 02/20/2024 11:00:00 AM
- MannKind Announces Enrollment Goal Completion of INHALE-1 Pediatric Diabetes Trial Utilizing Afrezza® • GlobeNewswire Inc. • 02/15/2024 11:05:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/05/2024 11:00:31 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/05/2024 11:00:23 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/05/2024 11:00:15 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/05/2024 11:00:15 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/05/2024 11:00:14 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/05/2024 11:00:12 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2024 11:06:28 AM
- MannKind and Sagard Healthcare Enter Into Royalty Purchase Agreement for Up to $200 Million • GlobeNewswire Inc. • 01/02/2024 11:05:00 AM
- MannKind Corporation to Present at 42nd Annual J.P. Morgan Healthcare Conference • GlobeNewswire Inc. • 12/28/2023 11:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/27/2023 09:15:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/16/2023 02:00:12 AM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 12/15/2023 09:09:12 PM
FEATURED Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • May 7, 2024 8:51 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM