J&J: EU approves labelling update for two diabetes drugs
(CercleFinance.com) - Johnson & Johnson's Janssen said on Friday that the European Commission has granted its approval to expand labelling for two diabetes drugs to include positive data on cardiovascular outcomes.
The update on Inovakana's and Vokanamet's labelling will include changes to the indication statement for the treatment of adults with insufficiently controlled type-2 diabetes mellitus, one of the most common forms of diabetes, as an adjunct to diet and exercise, Janssen said.
The decision means that the product information now includes data on the reduction in major adverse cardiovascular events (cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke) in patients with type-2 diabetes mellitus, in addition to the existing study results on improving glycemic control.
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The update on Inovakana's and Vokanamet's labelling will include changes to the indication statement for the treatment of adults with insufficiently controlled type-2 diabetes mellitus, one of the most common forms of diabetes, as an adjunct to diet and exercise, Janssen said.
The decision means that the product information now includes data on the reduction in major adverse cardiovascular events (cardiovascular mortality, non-fatal myocardial infarction, or non-fatal stroke) in patients with type-2 diabetes mellitus, in addition to the existing study results on improving glycemic control.
Copyright (c) 2018 CercleFinance.com. All rights reserved.