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J&J Files NDA for Combo Diabetes Drug - Analyst Blog

Posted
12/14/2012 11:10:00 AM
By: Zacks.com
Referenced Stocks:JNJ;LLY;MRK;NVO

Janssen Research & Development, LLC, a part of the Johnson & Johnson ( JNJ ) family of companies, recently announced the submission of a new drug application (NDA) for its fixed-dose combination of canagliflozin and metformin (immediate release) for the treatment of type II diabetes patients.

Approval of this fixed dose combination would provide patients with a convenient treatment option. Johnson & Johnson is currently seeking approval for canagliflozin in the US as well as the EU.

Johnson & Johnson had presented encouraging phase III data on canagliflozin at the annual meeting of the European Association for the Study of Diabetes (EASD) in October. The company presented results from CANVAS (CANagliflozin cardioVascular Assessment Study) - a prospective, double blind, placebo-controlled trial evaluating the efficacy, tolerability and cardiovascular safety of canagliflozin. The study involves 4,330 type II diabetes patients (adults) who are at higher risk for cardiovascular disease.

The data was presented from an 18-week sub-study involving 1,718 patients who had been under insulin therapy for an average of 7.1 years. Johnson & Johnson said that two doses of canagliflozin were evaluated in the study - 100 mg and 300 mg. Patients were randomized to receive either canagliflozin dosage or placebo.

Johnson & Johnson reported a significant decline in blood glucose levels when canagliflozin was used in addition to insulin therapy compared to placebo. Moreover, patients in the canagliflozin arms experienced a reduction in body weight compared to placebo.

While the occurrence of treatment-emergent adverse events (AEs) was similar across all treatment arms, discontinuations due to adverse events were higher in the 300 mg canagliflozin arm (5.3%) compared to the canagliflozin 100 mg and placebo arms (1.9% each).

Johnson & Johnson also presented results from another phase III study which showed that canagliflozin significantly reduced A1C levels compared to placebo, when used in addition to antihyperglycemic therapy in older type II diabetes patients with inadequate glycemic control.

We currently have a Neutral recommendation on Johnson & Johnson, which carries a Zacks #2 Rank (Buy). While we expect the company to continue facing headwinds in the form of pricing pressure, currency fluctuation, manufacturing issues and healthcare reform, we believe the company's diversified business model, lack of cyclicality, and strong financial position will continue helping it pave its way through tough situations.

Novo Nordisk ( NVO ), which has a strong presence in the diabetes market, also carries a Zacks #2 Rank.



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