Weekly Care Likely to Better Diabetic’s Health

Eli Lilly the world’s first insulin maker has been entitled by the

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European Commission for marketing Trulicity (dulaglutide), a novel injectable treatment for adults with type 2 diabetes. The once-weekly Trulicity may affect the Novo Nordisk’s widely used blockbuster Victoza (liraglutide) as it has demonstrated clinical superiority however there are safety concerns based on pre-clinical lab data which may result in an uncertain sales outcome in view of upcoming approvals from other companies.
Trulicity is a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) designed in an easy-to-use single-dose pen and can be taken any time of day, with or without meals. Studies reveal that Trulicity can help in lowering the A1C and blood sugar numbers and may even help to lose some weight. GLP-1 is a natural hormone, in prodding the body to release insulin when patients eat. Like other insulin products Trulicity can cause hypoglycemia, nausea, fainting and other symptoms and is contraindicated in thyroid patients.
Diabetes (type 1 and 2) is a chronic disease in which the body either does not properly produce, or use, the hormone insulin. It victimizes 29 million Americans and 382 million people around the globe with 90-95% occurrence of Type 2.
Launched in 2009, Victoza reached 2.3 million patients globally with a blockbuster sale of $418 million in 2010 and doubling to $1.04 billion in the first half of 2013. The analysts estimate the sales to quadruple to $4.07 billion in 2018. Tim Anderson, Bernstein analyst forecasts the sale of Trulicity to reach $1.3 billion by 2020. The current market of GLP-1 is around $3 billion.
Last year GlaxoSmithKline’s Tanzeum was approved by the FDA which is also a once-weekly GLP-1 agonist but unlike Trulicity Tanzeum failed to show superiority to Victoza. AstraZeneca after acquiring the Byetta from the dead alliance of the inventors Amylin and Eli Lilly launched Bydureon, which is another once-weekly treatment but it failed due to complicated delivery system, however approval for a new delivery system for Bydureon was received earlier this year.  Merck’s DPP-4 inhibitor Januvia, Sanofi’s Lyxumia (lixisenatide) and AstraZeneca’s once-a-month version in the pipeline is yet another reason for Trulicity to worry.
Although While Trulicity has been found as non-inferiorsuperior to blockbuster Victoza in head-to-head trials, its fate is dilemmatic with robust rivals anduncertain as there is a major concern of drug safety as per its black box warning regardingdue to increased risk for thyroid C-cell tumors based on pre-clinical studies. The stakes are high and the diabetes patient population is large so the outcome remains to be seen specially in view of the oncoming competition.

Author: Toshit

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