Janssen applies to FDA New Drug Application for Invokamet XRNovember 20, 2015
Janssen Research & Development, LLC has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for Invokamet extended release (XR).
In an announcement on Friday, Janssen explained that Invokamet XR is a once-daily therapy combining fixed doses of canagliflozin and metformin hydro-chloride XR in two tablets.
As Janssen said, ff approved, Invokamet XR will provide a new treatment option for adults with type 2 diabetes mellitus as an adjunctive treatment to diet and exercise to improve glycemic control.
Giving further detailed explanation, Janssen said that Invokamet XR would offer the combination of Invokana (canagliflozin), the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor in the United States, and extended release metformin, which is commonly prescribed as an initial therapy for the treatment of type 2 diabetes.
Invokana is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
“This submission to the FDA is evidence of Janssen’s continued commitment to bringing forth new treatment options for people with type 2 diabetes,” said James List, M.D., Ph.D., Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen.
“We look forward to working with the FDA to bring this combination therapy to adult patients with type 2 diabetes in need of new options,” List added.
Johnson Johnson’s pharmaceutical company noted that Invokamet, the first fixed-dose combination tablet in the United States combining canagliflozin and immediate release metformin hydro-chloride, received approval from the FDA in August 2014 for the treatment of adults with type 2 diabetes.
European Commission approved it in April 2014 under the name Vokanamet, for the treatment of adults with type 2 diabetes mellitus to improve glycemic control.