Bile

Prescription drugs' fine print is important – a toxicologist explains how to decode package inserts to take medications safely and increase their effectiveness

Retrieved on: 
Monday, April 24, 2023

With approximately 1.3 million emergency department visits in the U.S. caused by adverse drug events each year, patient education is becoming increasingly important.

Key Points: 
  • With approximately 1.3 million emergency department visits in the U.S. caused by adverse drug events each year, patient education is becoming increasingly important.
  • All prescription drugs come with instructions on how to safely and effectively use them.
  • Depending on the medication, there may be several types of information included: the patient package insert, medication guide and instructions for use.

What can I learn from package inserts?

    • An often overlooked part of the package insert is the prescribing information.
    • Though written primarily for health care professionals, it contains a wealth of information regarding the ways in which the medication interacts with the body.
    • If you’d like to follow along, a copy of the prescription information for Lipitor can be found here.

How does the drug work?

    • Pharmacodynamics refers to “what the drug does to the body,” which includes the mechanism of action as well as how other factors like drug concentration influences its effects.
    • First, the liver is the primary site that produces cholesterol in the body and the area the drug is meant to target.
    • And third, the drug increases the number of LDL cholesterol receptors on cell surfaces, ultimately increasing the catabolism, or metabolic breakdown, of LDL cholesterol.

Where does the drug go in my body?

    • The pharmacokinetics of a drug are determined by factors related to the chemical itself and the person taking the medication.
    • For Lipitor, the prescription insert does not specifically say where the drug goes in the body, but it does note that the volume of distribution is 381 liters.
    • On the other hand, chloroquine, an antimalarial drug that enters body fat, has a value of 15,000 liters.

Does the drug cause the effects or its byproducts?

    • Though the therapeutic effects of most drugs come from the chemical compound it’s made of, many break down into active metabolites in the body that also have some relevant biological effects.
    • Some medications are administered in an inactive form called a prodrug that the body converts into metabolites with the desired therapeutic effects.

How long will the drug be in my system?

    • Information about a drug’s half-life is found in the “Excretion” subsection under “Pharmacokinetics.” The half-life for Lipitor is approximately 14 hours.
    • This means that the drug’s effects may last even after the drug itself is out of your system.

Why do I need to take medications with food or at certain times?

    • For Lipitor specifically, the answer to this question can be found in the “Absorption” subsection under “Pharmacokinetics.” Food decreases the rate and extent of Lipitor’s absorption but doesn’t significantly affect LDL cholesterol reduction.
    • The upshot of all of this is written on the drug label on the outside of the package: Lipitor can be taken with or without food.

Why does my doctor ask about other drugs I’m taking?

    • For instance, two drugs may rely on the same enzyme system in the body to break them down.
    • Taking them at the same time can ultimately lead to higher-than-anticipated levels of either or both drugs in the body.

LifeNet Health LifeSciences launches TruVivo™, a pioneering all-human 2D+ hepatic system, to revolutionize compound discovery

Retrieved on: 
Tuesday, April 4, 2023

Their findings have been featured in multiple scientific poster presentations , including most recently at the 2023 Society of Toxicology annual meeting.

Key Points: 
  • Their findings have been featured in multiple scientific poster presentations , including most recently at the 2023 Society of Toxicology annual meeting.
  • "TruVivo delivers a superior combination of human relevance, reliability, simplicity, and longevity," said Louis Dias, General Manager of LifeNet Health LifeSciences.
  • "This technological breakthrough reflects LifeNet Health's continued commitment to accelerating discovery in the field of life sciences," said LifeNet Health President and CEO Rony Thomas.
  • "TruVivo will expedite drug development efforts, supporting lifesaving pharmaceuticals, treatments and cures – bringing a new platform to researchers around the world."

Olympus to Acquire Korean Gastrointestinal Stent Company Taewoong Medical Co., Ltd

Retrieved on: 
Friday, February 24, 2023

Taewoong Medical, a leading manufacturer of GI stents, offers a variety of medical devices including metallic stents designed for biliary tract, esophagus, colon, and duodenum treatments[5].

Key Points: 
  • Taewoong Medical, a leading manufacturer of GI stents, offers a variety of medical devices including metallic stents designed for biliary tract, esophagus, colon, and duodenum treatments[5].
  • "Taewoong Medical has developed a full portfolio of GI metal stents that will immediately enhance our already robust offering of GI devices.
  • Kyong-min Shin, President and CEO of Taewoong Medical stated, "For over three decades, Taewoong Medical has been a leading manufacturer of GI stents, renowned for its innovative technology and diverse product range.
  • Moving forward together with Olympus, Taewoong Medical will focus its capabilities to provide medical professionals and patients with superior products and services through continuous investment in R&D and manufacturing technology."

FDA Grants June 15, 2023 PDUFA Date to Albireo for Bylvay® in Alagille Syndrome

Retrieved on: 
Tuesday, February 14, 2023

With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023.

Key Points: 
  • With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023.
  • Over 90% of patients were pruritus responders and Bylvay was generally well tolerated; the overall incidence of treatment emergent adverse events (TEAEs) was similar to placebo.
  • “As an advocate for Alagille families, it is great to know physicians may have another drug treatment option for the debilitating pruritus that affects so many Alagille patients,” said Roberta Smith, President, Alagille Syndrome Alliance.
  • Alagille syndrome, or ALGS, is a rare, multisystem genetic disorder that the Company estimates impacts 25,000 people globally.

Obstetric and Neonatal Professionals Must Work More Closely with Pregnant People to Identify Liver Diseases Early

Retrieved on: 
Wednesday, February 1, 2023

“Most pregnant women and families of young children were never informed that liver health is an essential aspect of a healthy pregnancy and birth.

Key Points: 
  • “Most pregnant women and families of young children were never informed that liver health is an essential aspect of a healthy pregnancy and birth.
  • Existing nonalcoholic fatty liver disease (NAFLD) has been tied to intrahepatic cholestasis of pregnancy (ICP) , an issue with the flow of bile in the liver, which affects 1 in 300 pregnancies.
  • For any liver disease during pregnancy or early in life, early diagnosis is critical to access the complex, robust care required to mitigate issues.
  • If liver diseases are ignored during pregnancy, it can lead to serious health complications for both the mother and the baby.

Ipsen to Acquire Albireo Accelerating Growth in Rare Disease With Treatments for Several Pediatric Liver Diseases

Retrieved on: 
Monday, January 9, 2023

Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases.

Key Points: 
  • Ipsen (Euronext: IPN: ADR: IPSEY) and Albireo (Nasdaq: ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Albireo, a leading innovator in bile-acid modulators to treat pediatric and adult cholestatic liver diseases.
  • “Our Rare Disease franchise is strengthened with Bylvay, which, in addition to being the first-approved treatment in PFIC, has two further indications being investigated in rare liver conditions that are underserved.
  • “Our talented team at Albireo have advanced the first Phase III studies in three different pediatric liver diseases while discovering two promising new clinical stage bile acid modulators.
  • Goldman Sachs is acting as exclusive financial advisor to Ipsen and Orrick Herrington & Sutcliffe LLP as legal counsel to Ipsen.

Albireo Submits Bylvay® Alagille Syndrome Regulatory Filings to FDA and EMA

Retrieved on: 
Monday, December 19, 2022

BOSTON, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation application to the European Medicines Agency (EMA) seeking approval for a second Bylvay indication for use in patients with Alagille syndrome (ALGS) in the second half of 2023.

Key Points: 
  • “The clear results from our ASSERT Phase 3 data allowed the Company to swiftly submit FDA and EMA regulatory filings,” said Ron Cooper, President and Chief Executive Officer of Albireo.
  • Over 90% of patients were pruritus responders and Bylvay was generally well tolerated; the overall incidence of treatment emergent adverse events (TEAEs) was similar to placebo​.
  • No patients discontinued the study​ and 96% of patients rolled over into the open-label extension study.
  • Alagille syndrome, or ALGS, is a rare, multisystem genetic disorder that the Company estimates impacts 25,000 people globally.

HealthWell Foundation Opens Vitamins and Supplements Fund to Assist Individuals Living with Alagille Syndrome

Retrieved on: 
Wednesday, November 30, 2022

GERMANTOWN, Md., Nov. 30, 2022 /PRNewswire/ -- The HealthWell Foundation®, an independent non-profit that provides a financial lifeline for inadequately insured Americans, is proud to announce that it has launched a new fund to provide financial assistance to patients living with Alagille Syndrome. Through the new fund, HealthWell will provide up to $1,500 in financial assistance to eligible patients within the United States and U.S. territories who have annual household incomes up to 500 percent of the federal poverty level to obtain vitamins and supplements for the management of their condition.

Key Points: 
  • Alagille syndrome (ALGS) is a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys.
  • Because the body cannot properly absorb fats and fat-soluble vitamins (vitamins A, D, E, and K), affected children may also experience growth deficiencies and failure to thrive.
  • Vitamins and supplements are a critical component in managing the condition but are often costly and represent a financial hardship for many families," commented Roberta Smith, President, Alagille Syndrome Alliance.
  • To determine eligibility and apply for financial assistance, visit HealthWell's Alagille Syndrome Vitamins and Supplements Fund page.

American Liver Foundation Hosts the 31st Annual Irwin M. Arias Symposium

Retrieved on: 
Thursday, November 3, 2022

FAIRFIELD, N.J., Nov. 3, 2022 /PRNewswire/ -- The American Liver Foundation is pleased to host its 31st annual Irwin M. Arias Symposium, Bridging Basic Science and Liver Disease, on November 10th from 9AM to 5PM ET. This one-day virtual program brings together hundreds of leading biomedical scientists and physicians from across the globe and is designed to bridge the remarkable advances in basic biology and engineering with the understanding of liver diseases and their treatment.

Key Points: 
  • Virtual event, Bridging Basic Science and Liver Disease, brings together hundreds of leading biomedical scientists and physicians from across the globe
    FAIRFIELD, N.J., Nov. 3, 2022 /PRNewswire/ -- The American Liver Foundation is pleased to host its 31st annual Irwin M. Arias Symposium , Bridging Basic Science and Liver Disease,on November 10th from 9AM to 5PM ET.
  • Registration is free alfevents.org/ariassymposium
    "We are honored to host our 31st annual Arias Symposium and are so grateful to Dr. Irwin M. Arias , who is recognized throughout the world, for his lifetime of leadership in bridging the gap between scientists in the lab and physicians in the clinic," said Lorraine Stiehl, CEO, American Liver Foundation.
  • The American Liver Foundation is the nation's largest non-profit organization focused solely on promoting liver health and disease prevention.
  • The mission of the American Liver Foundation isto promote education, advocacy, support services and research for the prevention, treatment and cure of liver disease.

Intercept Announces New Data to be Presented in PBC, Liver Fibrosis due to NASH and Pipeline at AASLD The Liver Meeting® 2022

Retrieved on: 
Monday, October 31, 2022

MORRISTOWN, N.J., Oct. 31, 2022 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced multiple abstracts on obeticholic acid (OCA) and INT-787, a next-generation FXR agonist, will be presented at The Liver Meeting® 2022, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The Liver Meeting® will be held from November 4 – 8, 2022, in Washington, D.C.

Key Points: 
  • We are especially excited to share additional analyses of our pivotal REGENERATE study, which we believe further support the positive benefit:risk profile of OCA in liver fibrosis due to NASH.
  • The use of OCA for fibrosis due to NASH is investigational and has not been approved by the U.S. Food and Drug Administration or any other health authority.
  • Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH.
  • This press release contains forward-looking statements (FLS), including regarding resubmission and timing of Intercepts new drug application for OCA for treatment of liver fibrosis due to NASH.