In the Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee held on May 24th – 25th, 2016, the US Food and Drug Administration (FDA) has endorsed two new diabetic drugs i.e., Novo Nordisk’s IDegLira and Sanofi’s iGlarLixi – These are fixed-ratio combinations of Insulin Degludec (Tresiba®) and Liraglutide (Victoza®), and Lixisenatide and Lantus® respectively.
While IDegLira received a unanimous backing from the FDA panel i.e., 16-0. iGlarLixi won the approval with 12-2 votes. Both drugs were submitted under FDA’s New Drug Application (NDA) program.
Agenda Of The Advisory Committee Meeting
Ahead of the meeting, the FDA posted all the relevant information on their website in an accessible format. The agenda of the meeting was to:
- Discuss benefits of the fixed-dose combinations over conventional anti-diabetic therapies.
- Identify the patient populations for which the combinations would be most useful and successful.
- Prove the superiority of the combination treatment over early conventional treatments in terms of Glycemic control.
- Discuss why the combination is more effective than individually using either of the two medicines.
- Highlight the safety profile of iGlarlixi and IDegLira.
Various representative doctors from Novo Nordisk and Sanofi shed light on the rationale of new drug combination, their mechanisms of actions, efficacy, safety, dose titrations and capping, and benefit-risk ratio.
Both meetings began at 8:00 am in the morning on two consecutive days and were loaded with information, scientific data, statistics, questions and concerns. The application presentations from the said pharmaceutical firms were followed by presentations from the FDA that included clinical and statistical overview by designated clinical reviewers and mathematical statisticians. The presentations also entailed human factors evaluations for both drugs by FDA’s safety evaluators.
About Advisory Committee Meetings
FDA advisory committee consisted of a panel of independent and qualified experts who advised the administration on questions and concerns. Their advice carries substantial weight in regulatory decisions. While the FDA is not obliged to follow the committee’s recommendation, it takes the advice while reviewing the NDAs.
FDA Amendment Act of 2007 (FDAAA) requires that new drugs be referred to the advisory committee meeting. In the event of non-consultation, the FDA is required to provide a justification to the committee.
Diabetic Drugs — FDA Unanimously Endorses IdegLira
IDegLira is a fixed-combination of Insulin Degludec (Tresiba®) and Liraglutide (Victoza®) intended for once-daily injection. It is used for the treatment of adults with type 2 diabetes.
Degludec is a once-daily new-generation basal insulin analogue and Liraglutide, a once-daily GLP-1 analogue.
As soon as the presentations were finished, the FDA asked the panelists to discuss whether Novo Nordisk has provided sufficient data and evidence to support the clinical efficacy and safety of the drug. As is required, the pharmaceutical company provided the reference data along with the NDA dossier in September 2015 under the FDA’s Prescription Drug User Fee Act V (PDUFA V) regulation.
For a new drug, the NDA dossier should contain robust evidence based on data from clinical trials. For IDegLira, it was DUAL phase 3 clinical trial which enrolled approximately 3,000 people with type 2 diabetes.
Both Degludec and Liraglutide have separately been extensively studied in various other clinical trials.
The Advisory Committee gave a unanimous approval to the drug i.e., 16-0. Such an overwhelming approval should open new realms for treatment in otherwise difficult to treat diabetic patients. The approval comes across as a breath of fresh air for the pharmaceutical firm that looks forward to the review completion.
“We look forward to working with the FDA as they complete their review of IDegLira”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
IDegLira has already been approved in Europe and is marketed under the brand name Xultophy®.
Diabetic Drugs — FDA Backs iGlarLexi
A combination of long-acting Insulin Lantus and Lixisenatide (Lyxumia,) iGlarLixi is Sanofi’s new injectable medicine for the treatment of type 2 Diabetes. Once approved by the FDA, iGlarlixi is expected to create a new paradigm of treatment for diabetics.
Lixisenatide is a once-daily GLP-1 receptor agonist that is to be taken with meals. Basal Insulin Glargine is marketed as Lantus®.
When asked whether they approved the new drug product, the members of the Advisory Committee voted 12-2 in favor of Sanofi’s iGlarLixi.
The panelists approved the ideal patient profile of the drug that allowed a diabetic patient, having trouble controlling their blood sugar with a single drug, to switch to the combination for a better Glycemic control.
The decision has made Britt Meelby Jensen, Chief Executive Officer of Zealand, very happy. In a statement, the jubilant CEO said: “I am very pleased that the FDA Advisory Committee so clearly has recommended an approval of iGlarLixi in the US as a new treatment for adults with type 2 Diabetes.
This positive outcome, and the supportive conclusion on Lixisenatide as a stand-alone therapy, have taken us an important step closer to potentially having two medicines based on a Zealand invention being available in the US market later this year.”
IGlarLixi is a product of Zealand but is globally developed under the license of Sanofi.
This has been the second endorsement of the treatment duo in two days. The NDAs for both drugs are currently under a review in the FDA and will likely get an approval by mid-2016.
With Sanofi having invested $245 million for the “priority review” of the NDA over the competitor (Novo Nordisk,) the stakes are high for both companies. Both pharmaceutical firms seek to get their shaky Diabetes franchise back on track.