Diabetes Drug That Also Treats Obesity Could Make Billions

Being fat sucks. I’m not judging; I’ve been overweight all my life. Obesity puts you at risk for high blood pressure, heart disease, stroke, and even some cancers.
Then of course there’s Type 2 diabetes. The mother of all obesity-related complications keeps your body from regulating the sugar it needs as fuel, and can lead to all kinds of health issues, like kidney damage, heart disease, and even limb amputation.
That could change, if pharmaceutical companies can convince doctors that a new-ish class of drugs can attack Type II diabetes and the fatness that begets it—without killing patients. Earlier this month, at the Endocrine Society’s annual conference in Boston, Danish pharma Novo Nordisk presented three years of data showing that their diabetes drug liraglutide helped obese and prediabetic patients lose weight without undue risk. Which is big, for a drug that’s been flagged for causing cancer.
In rats, that is. Liraglutide—or Saxenda, as it’s known commercially for weight-loss—carries a black box warning from the FDA for giving thyroid tumors to rodents. However, the specific tumor-causing cell biology is different enough in rats that many endocrinologists don’t consider it a significant risk to human patients.
Many, but not all. Weight loss drugs are historically pretty risky. Remember Fen-Phen? It was great at helping people get skinny—as long as those people were OK with developing chronic heart problems. Fen-Phen was pulled from the market in 1997, and its maker had to pay billions of dollars in legal fees.
Liraglutide, in Saxenda form, might Continue reading

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Price controls on diabetes drugs, licenses for sales reps key features of pharmaceutical bill

Price controls on diabetes medication. Requiring pharmaceutical sales representatives to be licensed and annually report to the state on their activities. Mandating disclosure of any pharmaceutical-related contributions by nonprofits working in the health care sector.
These are just some of the changes proposed by Democratic Sen. Yvanna Cancela in an omnibus pharmaceutical bill introduced on Tuesday — changes she says are necessary in order to ensure patients have access to life-saving drugs and to bolster health care industry transparency. But pharmaceutical company lobbyists are already digging in their heels and saying it will reduce patients’ access to life-saving medicine and ignores the importance of private market competition.
A substantial portion of the bill, SB265, seeks to improve access to medically necessary diabetes drugs by implementing price controls, which pharmaceutical companies have long resisted. The legislation, which eight of Cancela’s Democratic colleagues have signed onto, would require the state Department of Health and Human Services to compile a list of “essential” drugs that treat diabetes, such as insulin and biguanides, and require drug manufacturers to reimburse purchasers — either the patient or the insurance company — when the manufacturer’s list price of the drug exceeds the highest price paid for the drug in certain countries or if it exceeds annual changes in the Consumer Price Index.
The goal, in Cancela’s view, is essentially to stabilize the cost of a drugs such as insulin that have existed for 95 years and yet have Continue reading

FDA approves Novo Nordisk diabetes drug Ozempic

(Reuters) - The U.S. Food and Drug Administration on Tuesday approved Novo Nordisk A/S’s diabetes drug Ozempic, setting the stage for a heated battle with Eli Lilly & Co’s Trulicity.
Ozempic, known generically as semaglutide, will compete with others in a class known as glucagon-like peptide-1 (GLP-1) analogs, which imitate an intestinal hormone that stimulates the production of insulin.
Ozempic is a once-weekly injection that Novo Nordisk hopes will take market share from Trulicity, which has been cutting into sales of Novo Nordisk’s once-daily Victoza. Novo Nordisk is also developing an oral form of semaglutide.
The company said it plans to price the drug at $676 per prescription, which it described as “at parity” to current market-leading drugs in the same class.
The approval comes as Novo Nordisk faces pricing competition to its existing diabetes products. The company is banking on Ozempic to help drive the overall growth of the GLP-1 market, which includes Trulicity and AstraZeneca Plc’s once-weekly Bydureon.
Novo Nordisk is betting that Ozempic’s proven heart benefit and weight-loss advantage over rival products will increase its attractiveness both to physicians and insurers.
Analysts on average expect annual sales of Ozempic to reach $3.17 billion by 2023, with sales of Trulicity, which was approved in the United States in late 2014, reaching $3.71 billion over the same period, according to Thomson Reuters data.
Analysts at Credit Suisse estimate that by 2022 Novo Nordisk will have captured roughly 60 percent of the GLP-1 market compared with an expect Continue reading

How Digital Health Care Can Help Prevent Chronic Diseases Like Diabetes

Diabetes is one of the most pervasive and expensive chronic diseases: It affects an estimated 30.3 million people in the United States and costs a staggering $245 billion per year to treat. In addition there are 84.1 million adults in the United States with high blood sugar levels in danger of developing type 2 diabetes. It is widely acknowledged that the most effective method of treating these prediabetics so they don’t become full-fledged diabetics is diabetes prevention programs (DPPs) that follow a protocol validated by the Centers for Disease Control and Prevention (CDC). But the challenge has been to get people to enroll in them in the first place and stick with them if they do.
Omada Health, a digital therapeutics firm focused on preventing obesity-related chronic conditions such as type 2 diabetes, has made significant strides in achieving both with the 120,000 prediabetics who have participated in its program. Its success demonstrates the potential of digital health services, and its approach can serve as a model for applying such services to other chronic diseases. We studied Omada’s program as part of our Harvard Medical School initiative to identify and share knowledge about innovative approaches to major health challenges that primary care providers play the lead in treating.
DPPs typically include in-person meetings of a small group of prediabetic adults who, with the guidance of a health coach, progress through a diet and lifestyle curriculum. The course usually consists of weekly sessions during the initial four months. Participants then receive monthly Continue reading

Essential Keys To Diagnosing And Treating PAD In Patients With Diabetes

Author(s):
Peripheral arterial disease (PAD) is an extremely prevalent, substantially underdiagnosed condition, which has a significant risk of morbidity and mortality. Recent data suggests that PAD affects nearly 18 million Americans and greater than 202 million globally.1,2 Patients with diabetes at highest risk include those age 50 or older, or those under age 50 with comorbid hypertension, hyperlipidemia or obesity. Individuals with a history of cardiovascular disease and those over age 65 are also at high risk.1,3
Complicating the ability to diagnose PAD, approximately 50 percent of PAD patients are asymptomatic while another 33 percent have atypical symptomatology.4 Unfortunately, once diagnosed with PAD, 20 percent will experience a life-altering cardiovascular complication such as a myocardial infarction or cerebrovascular accident while 30 percent will experience a life-ending cardiovascular complication.5
Why Diabetes And PAD Are Frequent Comorbid Conditions
Diabetes mellitus is also a global health emergency.6 As of 2016, 422 million people had diabetes worldwide, up from an estimated 382 million people in 2013 and 108 million in 1980.7,8 The prevalence of diabetes varies worldwide. It is greater in middle-aged people in developing countries and people over 65 years of age in developed countries such as the United States.9
The U.S. has the unfortunate distinction of having the third largest number of adults suffering from diabetes.6 Currently, 14.3 percent of the U.S. population has diabetes with over 36 percent undiagnosed.10 Over the last 17 years, the U.S. pre Continue reading