COVID19 Vaccines and other Regulatory Highlights

FDA Authorizes Pfizer/BioNTech and Moderna COVID-19 Vaccines
In December 2020, the U.S. FDA granted Emergency Use Authorization to Pfizer/BioNTech and Moderna for vaccines to prevent COVID-19 caused by SARS-CoV-2 infection. Moderna’s vaccine is indicated for use in individuals 18 and up, while the Pfizer/BioNTech vaccine is indicated for individuals as young as 16. Read More >>

Xolair Receives New Indication to Treat Nasal Polyps
Xolair® (omalizumab), which was already approved to treat asthma and chronic idiopathic urticaria (a recurring form of hives), is now indicated for use as an add-on maintenance treatment for nasal polyps in adults who have had an inadequate response to nasal corticosteroids. Read More >>

Label Update Required for Diabetes Drugs Containing Sitagliptin
The U.S. FDA has approved a label update for Merck’s Januvia® (sitagliptin), Janumet® (sitagliptin/metformin hydrochloride), and Janumet® XR (sitagliptin/metformin hydrochloride extended release). The labels for each product will reflect that drugs containing sitagliptin have not been proven to improve glycemic (blood sugar) control in pediatric patients age 10 to 17 who have type 2 diabetes. Read More >>

Saxenda Receives Expanded Approval for Weight Management
First FDA approved in 2014 to provide chronic weight management for certain adults, Saxenda is now also indicated for use in adolescents 12-17 years of age who weigh more than 60kg (132 pounds) and have an initial body mass index (BMI) that corresponds to 30kg/m2 (obese) or greater for adults. Read More >>