AstraZeneca India launches once-daily Xigduo® XR tablets for comprehensive management

14th February 2018: AstraZeneca Pharma India Limited (AstraZeneca India) has announced the launch of its innovative anti-diabetic combination once-daily therapy Xigduo® XR for treatment of adults with type 2 diabetes.

Xigduo® XR,is a product of AstraZeneca Group and is approved in 61 countries to dateincluding US, EU & Japan. It combines two anti-diabetic agents withcomplementary mechanisms of action, the widely recommended first linemonotherapy (metformin) with a clinically trusted dapagliflozin, an inhibitorof sodium-glucose cotransporter 2 (SGLT2), in a once-daily oral tablet. Thiscombination backed by the XR (extended release) technology provides 24-hoursugar control offering physicians and patients a new approach to early achievementof treatment goals.

XIGDUO® XRis indicated as an adjunct to diet and exercise to improve glycemic control inadults with type 2 diabetes mellitus when treatment with both dapagliflozin andmetformin is appropriate.

SGLT2inhibitors are a relatively new class of medicines that provide comprehensivecontrol through HbA1c reduction, blood pressure control and weight reductionalong with clinically proven better cardiovascular outcomes. Earlier in 2015,AstraZeneca India had launched the first CDSCO approved SGLT2 inhibitor inIndia under the brand name Forxiga® (dapagliflozin).

Commentingon the launch, Mr. Gagan Singh Bedi, Managing Director, AstraZeneca PharmaIndia Limited said, “Over 74 million patients are affected by diabetes todayand a significant number do not reach their treatment goals. We believe thisnovel once-daily combination therapy of dapagliflozin and metformin can addressan unmet medical need by offering a comprehensive and convenient treatmentoption for the Indian phenotype patient predisposed to comorbidities such asblood pressure and weight gain[1]. Xigduo® XR is an exciting new addition toour diabetes portfolio and signifies our commitment to improve diabetes carethrough innovative treatment solutions”

Eight in tenIndians display a characteristic feature of the Indian Phenotype (greaterdegree of central body obesity, higher insulin resistance and characteristicdyslipidemia) making them highly vulnerable to developing the nexus of type 2diabetes, obesity and hypertension. Clinical evidence further reveals thatIndian diabetic patients have comorbidities such as hypertension and abdominalobesity and are at two-fold risk of cardiovascular and 40-70% increased risk ofrenal complications[2]. Xigduo® XR’s unique mode of action offers an alternatetreatment solution that caters to these complications in Indian diabeticpatients.

Dr. AnildaDsouza, Head Medical Affairs, AstraZeneca India said, “Type 2 diabetes is aprogressive disease and we are pleased to bring this innovative treatmentoption for physicians and patients that combines two trusted agents to helpintensify the treatment right from the start and has the potential to delay thedisease progression”

Substantialdelays in treatment intensification in patients with type 2 diabetes is animportant barrier to optimal patient outcomes[3]. XIGDUO® XR acts tosignificantly lower A1C levels by reducing circulating blood sugar, decreasingthe amount of glycated hemoglobin in the body. XIGDUO® XR does this through itsmulti-level action: its metformin component improves insulin sensitivity,increases peripheral glucose uptake and utilization, and reduces glucoseproduction by the liver and its absorption by the intestine; and itsdapagliflozin component prevents the kidneys from reabsorbing glucose and helpsincrease glucose excretion. 

XIGDUO® XRis available in multiple dosage strengths of dapagliflozin and metformin HClextended-release including 10/500 mg and 10/1000 mg and the starting dose canbe individualized based on each patient’s current treatment regimen. It is notrecommended for patients with type 1 diabetes mellitus or diabeticketoacidosis.

Xigduo® XRjoins the family of SGLT2i brands (Forxiga) in AstraZeneca’s strong diabetesportfolio. AstraZeneca offers products in three novel and fast- growing classesof diabetes treatments: DPP4, SGLT-2 and GLP-1. AstraZeneca India has twopatented brands-Onglyza® (Saxagliptin) and Kombiglyze™ XR in the DPP4i segment,Bydureon in the GLP1 Analog treatment segment and FORXIGA® & XIGDUO® XR inthe SGLT2i segment.

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