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Madrigal announces two-year results from Phase 3 MAESTRO-NAFLD-1 trial

Madrigal announces two-year results from Phase 3 MAESTRO-NAFLD-1 trial

Madrigal Pharmaceuticals (MDGL) announced positive two-year results from the open-label compensated MASH cirrhosis arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients in the study achieved significant improvements from baseline in liver stiffness, liver fat, fibrosis biomarkers, liver volume and risk scores for clinically significant portal hypertension, CSPH. Among patients with CSPH at baseline, 65% moved into lower risk categories by year two. Among patients with probable CSPH at baseline, 57% moved into the no/low CSPH category as compared to 14% who moved into the CSPH category by year two. Improvement in CSPH risk was statistically significant compared to baseline. Similar shifts to lower risk categories were observed in an analysis using a more stringent modified Baveno criteria that incorporates magnetic resonance elastography and the Enhanced Liver Fibrosis test as additional evidence for CSPH risk. Safety data were consistent with previous studies and Rezdiffra was well-tolerated with a low rate of discontinuation due to adverse events. The most common adverse events were diarrhea, COVID-19 and nausea. There were two deaths unrelated to Rezdiffra.
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Obesity drug prices are dropping, but getting a steady supply remains a challenge
Obesity drug prices are dropping, but getting a steady supply remains a challenge

San Francisco Chronicle​

time21 minutes ago

  • San Francisco Chronicle​

Obesity drug prices are dropping, but getting a steady supply remains a challenge

Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging. The medications still amount to around $500 per month for those without insurance — out of reach for many patients. And even for people with insurance, coverage remains uneven. 'The medications should be available, the question is at what price and can people sustain that,' said Matt Maciejewski, a Duke University professor who studies obesity treatment coverage. Doctors say the situation forces them to get creative in treating patients, but there's hope that prices may fall more in the future. The drugs are still in high demand Wegovy and Zepbound are part of a wave of obesity medications known as GLP-1 receptor agonists that have soared in popularity. Zepbound brought in $2.3 billion in U.S. sales during this year's first quarter, making it one of drugmaker Eli Lilly's best sellers. Novo Nordisk says Wegovy has about 200,000 weekly prescriptions in the U.S., where it brought in nearly $1.9 billion in first-quarter sales. Insurance coverage is increasing — for some The benefits consultant Mercer says more businesses with 500 or more employees are adding coverage of the injected drugs for their workers and family members. And Novo says 85% of its patients who have coverage in the U.S. pay $25 or less per month. Plus some patients with diabetes can get coverage of the GLP-1 drugs Ozempic and Mounjaro from Novo and Lilly that are approved to treat that condition. But most state and federally funded Medicaid programs don't cover the drugs for obesity and neither does Medicare, the federal program mainly for people age 65 and older. Even the plans that cover the drugs often pay only a portion of the bill, exposing patients to hundreds of dollars in monthly costs, said Dr. Beverly Tchang. Drugmakers offer help with these out-of-pocket costs, but that assistance can be limited. 'Coverage is not the same as access,' said Tchang, a New York-based doctor who serves as a paid advisor to both Novo and Lilly. But coverage remains inconsistent Bill-payers like employers are nervous about drugs that might be used by a lot of people indefinitely. Some big employers have dropped coverage of the drugs due to the expense. Pharmacy benefit managers, or PBMs, also are starting to pick one brand over the other as they negotiate deals with the drugmakers. One of the nation's largest PBMs, run by CVS Health, dropped Zepbound from its national formulary, or list of covered drugs, on July 1 in favor of Wegovy. That forced Tchang to figure out another treatment plan for several patients, many of whom took Zepbound because it made them less nauseous. Dr. Courtney Younglove's office sends prospective patients a video link showing them how to check their insurer's website for coverage of the drugs before they visit. 'Then some of them just cancel their appointment because they don't have coverage,' the Overland Park, Kansas, doctor said. Cheaper compounded drugs are still being sold Compounding pharmacies and other entities were allowed to make off-brand, cheaper copies of Wegovy and Zepbound when there was a shortage of the drugs. But the U.S. Food and Drug Administration determined earlier this year that the shortage had ended. That should have ended the compounded versions, but there is an exception: Some compounding is permitted when a drug is personalized for the patient. The health care company Hims & Hers Health offers compounded doses of semaglutide, the drug behind Wegovy, that adjust dose levels to help patients manage side effects. Hims says these plans start at $165 a month for 12 months, with customers paying in full upfront. It's a contentious issue. Eli Lilly has sued pharmacies and telehealth companies trying to stop them from selling compounded versions of its products. Novo recently ended a short-lived partnership with Hims to sell Wegovy because the telehealth company continued compounding. Novo says the compounded versions of its drug put patient safety at risk because ingredients are made by foreign suppliers not monitored by US regulators. Hims says it checks all ingredients to make sure they meet U.S. quality and safety standards. It also uses a third-party lab to verify that a drug's strength is accurately labeled. Prices have dropped Both drugmakers are selling most of their doses for around $500 a month to people without insurance, a few hundred dollars less than some initial prices. Even so, that expense would eat up about 14% of the average annual per person income in the U.S., which is around $43,000. There are some factors that may suppress prices over time. Both companies are developing pill versions of their treatments. Those could hit the market in the next year or so, which might drive down prices for the older, injectable doses. Younglove said some of her patients save as much as 15% by getting their doses shipped from a pharmacy in Canada. They used to get them from an Israeli pharmacy until the Canadians dropped their prices. She says competition like this, plus the introduction of pill versions, will pressure U.S. prices. 'I think price wars are going to drive it down,' she said. 'I think we are in the early stages. I have hope.' ___

Obesity drug prices are dropping, but getting a steady supply remains a challenge
Obesity drug prices are dropping, but getting a steady supply remains a challenge

Boston Globe

timean hour ago

  • Boston Globe

Obesity drug prices are dropping, but getting a steady supply remains a challenge

Doctors say the situation forces them to get creative in treating patients, but there's hope that prices may fall more in the future. The drugs are still in high demand Wegovy and Zepbound are part of a wave of obesity medications known as GLP-1 receptor agonists that have soared in popularity. Zepbound brought in $2.3 billion in U.S. sales during this year's first quarter, making it one of drugmaker Eli Lilly's best sellers. Advertisement Novo Nordisk says Wegovy has about 200,000 weekly prescriptions in the U.S., where it brought in nearly $1.9 billion in first-quarter sales. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up Insurance coverage is increasing — for some The benefits consultant Mercer says more businesses with 500 or more employees are adding coverage of the injected drugs for their workers and family members. And Novo says 85% of its patients who have coverage in the U.S. pay $25 or less per month. Plus some patients with diabetes can get coverage of the GLP-1 drugs Ozempic and Mounjaro from Novo and Lilly that are approved to treat that condition. But most state and federally funded Medicaid programs don't cover the drugs for obesity and neither does Medicare, the federal program mainly for people age 65 and older. Advertisement Even the plans that cover the drugs often pay only a portion of the bill, exposing patients to hundreds of dollars in monthly costs, said Dr. Beverly Tchang. Drugmakers offer help with these out-of-pocket costs, but that assistance can be limited. 'Coverage is not the same as access,' said Tchang, a New York-based doctor who serves as a paid advisor to both Novo and Lilly. But coverage remains inconsistent Bill-payers like employers are nervous about drugs that might be used by a lot of people indefinitely. Some big employers have dropped coverage of the drugs due to the expense. Pharmacy benefit managers, or PBMs, also are starting to pick one brand over the other as they negotiate deals with the drugmakers. One of the nation's largest PBMs, run by CVS Health, dropped Zepbound from its national formulary, or list of covered drugs, on July 1 in favor of Wegovy. That forced Tchang to figure out another treatment plan for several patients, many of whom took Zepbound because it made them less nauseous. Dr. Courtney Younglove's office sends prospective patients a video link showing them how to check their insurer's website for coverage of the drugs before they visit. 'Then some of them just cancel their appointment because they don't have coverage,' the Overland Park, Kansas, doctor said. Cheaper compounded drugs are still being sold Compounding pharmacies and other entities were allowed to make off-brand, cheaper copies of Wegovy and Zepbound when there was a shortage of the drugs. But the U.S. Food and Drug Administration determined earlier this year that the shortage had ended. That should have ended the compounded versions, but there is an exception: Some compounding is permitted when a drug is personalized for the patient. The health care company Hims & Hers Health offers compounded doses of semaglutide, the drug behind Wegovy, that adjust dose levels to help patients manage side effects. Hims says these plans start at $165 a month for 12 months, with customers paying in full upfront. Advertisement It's a contentious issue. Eli Lilly has sued pharmacies and telehealth companies trying to stop them from selling compounded versions of its products. Novo recently ended a short-lived partnership with Hims to sell Wegovy because the telehealth company continued compounding. Novo says the compounded versions of its drug put patient safety at risk because ingredients are made by foreign suppliers not monitored by US regulators. Hims says it checks all ingredients to make sure they meet U.S. quality and safety standards. It also uses a third-party lab to verify that a drug's strength is accurately labeled. Prices have dropped Both drugmakers are selling most of their doses for around $500 a month to people without insurance, a few hundred dollars less than some initial prices. Even so, that expense would eat up about 14% of the average annual per person income in the U.S., which is around $43,000. There are some factors that may suppress prices over time. Both companies are developing pill versions of their treatments. Those could hit the market in the next year or so, which might drive down prices for the older, injectable doses. Younglove said some of her patients save as much as 15% by getting their doses shipped from a pharmacy in Canada. They used to get them from an Israeli pharmacy until the Canadians dropped their prices. She says competition like this, plus the introduction of pill versions, will pressure U.S. prices. Advertisement 'I think price wars are going to drive it down,' she said. 'I think we are in the early stages. I have hope.'

Obesity drug prices are dropping, but getting a steady supply remains a challenge
Obesity drug prices are dropping, but getting a steady supply remains a challenge

Hamilton Spectator

timean hour ago

  • Hamilton Spectator

Obesity drug prices are dropping, but getting a steady supply remains a challenge

Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging. The medications still amount to around $500 per month for those without insurance — out of reach for many patients. And even for people with insurance, coverage remains uneven. 'The medications should be available, the question is at what price and can people sustain that,' said Matt Maciejewski, a Duke University professor who studies obesity treatment coverage. Doctors say the situation forces them to get creative in treating patients, but there's hope that prices may fall more in the future. The drugs are still in high demand Wegovy and Zepbound are part of a wave of obesity medications known as GLP-1 receptor agonists that have soared in popularity. Zepbound brought in $2.3 billion in U.S. sales during this year's first quarter, making it one of drugmaker Eli Lilly's best sellers. Novo Nordisk says Wegovy has about 200,000 weekly prescriptions in the U.S., where it brought in nearly $1.9 billion in first-quarter sales. Insurance coverage is increasing — for some The benefits consultant Mercer says more businesses with 500 or more employees are adding coverage of the injected drugs for their workers and family members. And Novo says 85% of its patients who have coverage in the U.S. pay $25 or less per month. Plus some patients with diabetes can get coverage of the GLP-1 drugs Ozempic and Mounjaro from Novo and Lilly that are approved to treat that condition. But most state and federally funded Medicaid programs don't cover the drugs for obesity and neither does Medicare, the federal program mainly for people age 65 and older. Even the plans that cover the drugs often pay only a portion of the bill, exposing patients to hundreds of dollars in monthly costs, said Dr. Beverly Tchang. Drugmakers offer help with these out-of-pocket costs, but that assistance can be limited. 'Coverage is not the same as access,' said Tchang, a New York-based doctor who serves as a paid advisor to both Novo and Lilly. But coverage remains inconsistent Bill-payers like employers are nervous about drugs that might be used by a lot of people indefinitely. Some big employers have dropped coverage of the drugs due to the expense. Pharmacy benefit managers, or PBMs, also are starting to pick one brand over the other as they negotiate deals with the drugmakers. One of the nation's largest PBMs, run by CVS Health, dropped Zepbound from its national formulary, or list of covered drugs, on July 1 in favor of Wegovy. That forced Tchang to figure out another treatment plan for several patients, many of whom took Zepbound because it made them less nauseous. Dr. Courtney Younglove's office sends prospective patients a video link showing them how to check their insurer's website for coverage of the drugs before they visit. 'Then some of them just cancel their appointment because they don't have coverage,' the Overland Park, Kansas, doctor said. Cheaper compounded drugs are still being sold Compounding pharmacies and other entities were allowed to make off-brand, cheaper copies of Wegovy and Zepbound when there was a shortage of the drugs. But the U.S. Food and Drug Administration determined earlier this year that the shortage had ended. That should have ended the compounded versions, but there is an exception: Some compounding is permitted when a drug is personalized for the patient. The health care company Hims & Hers Health offers compounded doses of semaglutide, the drug behind Wegovy, that adjust dose levels to help patients manage side effects. Hims says these plans start at $165 a month for 12 months, with customers paying in full upfront. It's a contentious issue. Eli Lilly has sued pharmacies and telehealth companies trying to stop them from selling compounded versions of its products. Novo recently ended a short-lived partnership with Hims to sell Wegovy because the telehealth company continued compounding. Novo says the compounded versions of its drug put patient safety at risk because ingredients are made by foreign suppliers not monitored by US regulators. Hims says it checks all ingredients to make sure they meet U.S. quality and safety standards. It also uses a third-party lab to verify that a drug's strength is accurately labeled. Prices have dropped Both drugmakers are selling most of their doses for around $500 a month to people without insurance, a few hundred dollars less than some initial prices. Even so, that expense would eat up about 14% of the average annual per person income in the U.S., which is around $43,000. There are some factors that may suppress prices over time. Both companies are developing pill versions of their treatments. Those could hit the market in the next year or so, which might drive down prices for the older, injectable doses. Younglove said some of her patients save as much as 15% by getting their doses shipped from a pharmacy in Canada. They used to get them from an Israeli pharmacy until the Canadians dropped their prices. She says competition like this, plus the introduction of pill versions, will pressure U.S. prices. 'I think price wars are going to drive it down,' she said. 'I think we are in the early stages. I have hope.' ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group. The AP is solely responsible for all content.

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