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First system of mobile medical apps for data sharing approved for marketing by FDA

The US Food and Drug Administration have approved the first set of mobile medical apps that allow people with diabetes to share data from a continuous glucose monitor automatically and securely to other people in real time using an Apple mobile device.

The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows people with diabetes to share their continuous glucose monitoring (CGM) data through a legally marketed device that is available on mobile devices. Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. This particular system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of an individual’s CGM data.

Once-weekly injectable dulaglutide now available for prescription in the UK
Developed and manufactured by Eli Lilly and Company, Trulicity® (dulaglutide) is now available to be prescribed in the UK for people with type 2 diabetes. 

The new treatment is a glucagon-like peptide 1 receptor agonist solution and is indicated to improve glycaemic control in adults. It can be used as a monotherapy (recommended dosage 0.75 mg once weekly) in people for whom metformin is inappropriate or contraindicated, and it can be used as an add-on therapy with other glucose-lowering medicines, including insulin. The recommended dosage here is 1.5 mg once weekly or 0.75 mg for potentially vulnerable populations, such as people aged 75 years and older.

Toujeo® receives positive opinion in Europe
The Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the approval of Sanofi’s Toujeo® (insulin glargine [rDNA origin] injection, 300 unit/mL), a next-generation once-daily basal insulin for the treatment of adults with type 1 and type 2 diabetes.

The European Commission is expected to make a final decision on granting marketing authorisation for Toujeo in the EU in the coming months. It is approved in the US by the US Food and Drug Administration.

Allpresan® Diabetic Foot Foam Cream launched
Neubourg Pharma UK has launched Allpresan® Diabetic Foot Foam Cream. It is available in two presentations (Allpresan® BASIC [5% urea] and Allpresan® INTENSIVE [10% urea]) and is clinically formulated to treat and prevent dry cracked skin and calluses on diabetic feet. It counteracts pressure marks and protects against infection and ulceration.

The foam formulation of the cream forms a protective mesh on the skin on application so that skin is able to breath and is protected from the environment. 

Unlike conventional creams, Allpresan® foam creams are recommended for use between the toes, as well as the whole foot and around any wound edges.

Licence extension for liraglutide in Europe
Victoza® (liraglutide) has received an extension on its medical licence by the European Commission for use in adults with type 2 diabetes and moderate renal impairment (stage 3 chronic kidney disease) in the UK.

The licence extension for liraglutide was based on efficacy and safety data from the LIRA-RENAL phase 3b clinical trial, which trialled the drug among people with moderate renal impairment. Over 26 weeks, liraglutide 1.8 mg showed superior HbA1c reduction and significant weight reduction (Victoza® is not indicated for weight management) with no worsening of renal function compared with placebo in adults receiving anti-diabetes tablets or insulin or both to control their type 2 diabetes.

The US Food and Drug Administration have approved the first set of mobile medical apps that allow people with diabetes to share data from a continuous glucose monitor automatically and securely to other people in real time using an Apple mobile device.

The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows people with diabetes to share their continuous glucose monitoring (CGM) data through a legally marketed device that is available on mobile devices. Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. This particular system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of an individual’s CGM data.

Once-weekly injectable dulaglutide now available for prescription in the UK
Developed and manufactured by Eli Lilly and Company, Trulicity® (dulaglutide) is now available to be prescribed in the UK for people with type 2 diabetes. 

The new treatment is a glucagon-like peptide 1 receptor agonist solution and is indicated to improve glycaemic control in adults. It can be used as a monotherapy (recommended dosage 0.75 mg once weekly) in people for whom metformin is inappropriate or contraindicated, and it can be used as an add-on therapy with other glucose-lowering medicines, including insulin. The recommended dosage here is 1.5 mg once weekly or 0.75 mg for potentially vulnerable populations, such as people aged 75 years and older.

Toujeo® receives positive opinion in Europe
The Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the approval of Sanofi’s Toujeo® (insulin glargine [rDNA origin] injection, 300 unit/mL), a next-generation once-daily basal insulin for the treatment of adults with type 1 and type 2 diabetes.

The European Commission is expected to make a final decision on granting marketing authorisation for Toujeo in the EU in the coming months. It is approved in the US by the US Food and Drug Administration.

Allpresan® Diabetic Foot Foam Cream launched
Neubourg Pharma UK has launched Allpresan® Diabetic Foot Foam Cream. It is available in two presentations (Allpresan® BASIC [5% urea] and Allpresan® INTENSIVE [10% urea]) and is clinically formulated to treat and prevent dry cracked skin and calluses on diabetic feet. It counteracts pressure marks and protects against infection and ulceration.

The foam formulation of the cream forms a protective mesh on the skin on application so that skin is able to breath and is protected from the environment. 

Unlike conventional creams, Allpresan® foam creams are recommended for use between the toes, as well as the whole foot and around any wound edges.

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Licence extension for liraglutide in Europe
Victoza® (liraglutide) has received an extension on its medical licence by the European Commission for use in adults with type 2 diabetes and moderate renal impairment (stage 3 chronic kidney disease) in the UK.

The licence extension for liraglutide was based on efficacy and safety data from the LIRA-RENAL phase 3b clinical trial, which trialled the drug among people with moderate renal impairment. Over 26 weeks, liraglutide 1.8 mg showed superior HbA1c reduction and significant weight reduction (Victoza® is not indicated for weight management) with no worsening of renal function compared with placebo in adults receiving anti-diabetes tablets or insulin or both to control their type 2 diabetes.

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