FDA Approvals Roundup: Mounjaro and Radicava ORS

RoundupsRoundups | 18 May 2022 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Mounjaro okayed as dual-targeted therapy for type 2 diabetes
Eli Lilly’s Mounjaro (tirzepatide; injection) has been approved for improving blood sugar control in adults with type 2 diabetes, in combination with diet and exercise.
 
Mounjaro is a dual agonist for the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) hormones, which are involved in blood sugar control.
 
Three different doses of Mounjaro (5, 10, and 15 mg) were evaluated in five clinical trials as a stand-alone therapy or add-on to other diabetes medicines. Mounjaro’s efficacy was compared with placebo, a GLP-1 receptor agonist (semaglutide), and two long-acting insulin analogs.
 
In patients receiving the highest dose, 15 mg of Mounjaro, hemoglobin A1c (HbA1c) levels were lowered by 1.6% more than placebo when the study drug was used as stand-alone therapy, and 1.5% more than placebo when used in combination with a long-acting insulin. HbA1c levels were lowered by 0.5% more than semaglutide, 0.9% more than insulin degludec, and 1.0% more than insulin glargine in patients receiving the 15-mg dose.
 
Obesity was common among study participants. Among those receiving the maximum dose, average weight loss was 23 lbs more than placebo when both were used with insulin, compared with 15 lbs more than placebo when neither was used with insulin. For the same dose, average weight loss was 12 lbs more than semaglutide, 29 lbs more than insulin degludec, and 27 lbs more than insulin glargine. Patients receiving insulin without Mounjaro tended to gain weight during the study.
 
Mounjaro received priority review designation for this indication.
 
The drug comes with a boxed warning for risk of thyroid C-cell tumors.
 
New indications
Radicava oral form approved for treating ALS
Mitsubishi Tanabe’s Radicava ORS (edaravone oral suspension) has received supplemental approval as an oral treatment for adults with amyotrophic lateral sclerosis (ALS).
 
Radicava was originally approved in 2017 as an intravenous infusion (IV) therapy for the progressive degenerative disease. The current approval, for Radicava ORS, used the 505(b)(2) pathway, which allows drugs to be approved based in part on data from studies conducted by other parties.
 
The efficacy of Radicava ORS was based on fundings from a bioavailability study comparing IV Radicava and Radicava ORS. Efficacy of IV Radicava was previously demonstrated in a 6-month clinical trial in 137 patients randomized to receive Radicava or placebo. At week 24, patients receiving Radicava showed less decline on a clinical assessment of daily functioning compared with those receiving placebo.
 
Radicava’s supplemental drug application was granted priority review and breakthrough and orphan drug designations.

 

 

© 2022 Regulatory Affairs Professionals Society.

Tags: FDA, US

Discover more of what matters to you

20;25;