Janssen Research & Development, LLC, a part of the
Johnson & Johnson
) 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
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
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
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.
), which has a strong presence in the diabetes market, also
carries a Zacks #2 Rank.
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