Health

Europe Approves Amgen’s First-in-Class Cholesterol Drug

Published

9 years ago

July 22, 2015

Oakland Post

This April 20, 2010, file photo, shows an exterior view of Amgen offices in Fremont, Calif. Biotech drugmaker Amgen Inc. reports quarterly earnings on Tuesday, July 29, 2014. (AP Photo/Paul Sakuma)

This April 20, 2010, file photo, shows an exterior view of Amgen offices in Fremont, Calif. (AP Photo/Paul Sakuma)

MATTHEW PERRONE, AP Health Writer

WASHINGTON (AP) — Amgen on Tuesday received European approval for its first-of-a-kind cholesterol drug that lowers levels of the artery-clogging substance more than older drugs that have been prescribed for decades.

The highly-anticipated decision introduces a new option for patients at risk for heart disease. But questions remain about the drug’s price — estimated by one analyst at about $3,750 per year outside the U.S. — and its ability to reduce heart attack and death in the long term.

The European Commission cleared Repatha for patients with dangerously high cholesterol levels, including those with inherited conditions that drive up levels of the wax-like substance. The injectable drug may also be used by patients who cannot control their cholesterol with older statin drugs, or cannot tolerate them due to side effects, the group said.

Repatha is the first in a new class of medications that lower bad cholesterol more than statins, which have been the standard treatment for over 20 years.

The U.S. Food and Drug Administration is scheduled to make a decision on a similar drug from Sanofi and Regeneron Pharmaceuticals this Friday. The FDA’s target date for reviewing Amgen’s drug is Aug. 27.

Both drugs lower low-density lipoprotein, or LDL, cholesterol more powerfully and in a different ways than currently available drugs. They block a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood. Adding the new drugs to older statins reduces LDL cholesterol by about 40 percent to 60 percent. Statins alone generally lower levels of bad cholesterol by about 25 to 35 percent.

But the prospect of introducing pricey, injectable drugs for one of the most common medical conditions in the world is drawing concerns from health insurers, providers and payers. Some analysts estimate the drugs could cost $10,000 or more per year in the U.S.

A spokeswoman for Thousand Oaks, California-based Amgen Inc. declined to offer specifics on pricing Tuesday.

“Our prices are managed with consideration to competition, the local pricing and reimbursement environment and patient-cost sharing obligation, which vary considerably by country,” said Kristen Davis, in a statement.

Deutsche Bank analyst Robyn Karnauskas said it will take time to establish Repatha’s pricing in Europe, but she estimates the drug’s price outside the U.S. will average about $3,750 per year. She expects European sales of $26 million this year, according to a research note.

Repatha and other PCSK9 drugs are expected to grow into blockbuster products, though prescribing may be limited at first by strict reimbursement.

Doctors are awaiting studies of whether Repatha and similar drugs actually result in fewer heart attacks and deaths in patients with high cholesterol. Preliminary analyses published earlier this year suggest patients taking the new drugs had half the risk of dying or suffering a heart problem compared to those receiving older drugs. But definitive results aren’t expected until 2017 or later.

Global Data expects the entire class of PCSK9 drugs — including drugs from Sanofi and Pfizer — to generate sales of $17.8 billion by 2023.

Evercore ISI analyst Mark Schoenbaum noted the European Commission granted Repatha “a broad label,” encompassing many patients with various forms of high cholesterol. However, he said in a research note that “today’s decision has very little read across to the U.S.”

Amgen shares slipped 38 cents to $163.96 in afternoon trading Tuesday. Its shares are up more than 37 percent over the past year.

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Report: Black Women Doctors are Underrepresented in Health Care Sector

Physician retention in California has decreased over the years for women doctors of color, a report by the Physicians for a Healthy California stated. According to the report, women physicians are more likely to experience burnout than their male counterparts, a trend that worsened during the COVID-19 pandemic.

Published

4 hours ago

May 3, 2024

Oakland Post

The report states that Black and Latino physicians are underrepresented in the healthcare industry. Only 2.8% of physicians are Black and 5.5% are Latino across the state of California.

By California Black Media

Physician retention in California has decreased over the years for women doctors of color, a report by the Physicians for a Healthy California stated.

According to the report, women physicians are more likely to experience burnout than their male counterparts, a trend that worsened during the COVID-19 pandemic.

The report states that Black and Latino physicians are underrepresented in the healthcare industry. Only 2.8% of physicians are Black and 5.5% are Latino across the state of California.

It also noted that women doctors of color are often assigned to serve in vulnerable and under-resourced communities.

“It is critical for health care organizations to implement effective strategies focused on the retention of this important group of clinicians,” the report stated.

Women doctors of color face career dissatisfaction, contributing to the low retention rates in California’s healthcare industry. The burnout particularly experienced by female doctors of color stems from workplace harassment and perceived lack of value at work.

Additionally, moral injury was another key factor driving women physicians of color away from the workforce. Unlike burnout, moral injury is defined as “the betrayal of what’s right by someone who holds legitimate authority in a high-stakes situation.”

Currently, two of the nine California regions used in the framework of the report — the Inland Empire and San Joaquin Valley — have less than 50 primary care doctors. Physician shortages are projected to get worse over the next few years.

By 2030, the report indicates, the demand for physicians will exceed the supply by at least 12%.

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Gov. Newsom, Attorney General Bonta Back Bill to Allow California to Host Arizona Abortion Care

Gov. Gavin Newsom and Attorney General Rob Bonta announced last week that they are backing a bill introduced by the state legislative women’s caucus that would allow Arizona-based doctors to provide abortion care in California to patients from Arizona. Senate Bill (SB) 233 was authored in response to the Arizona Supreme Court’s decision on April 9 that an 1864 ban on abortion in the state is enforceable.

Published

5 hours ago

May 3, 2024

Oakland Post

Gov. Gavin Newsom and Attorney General Rob Bonta.

By California Black Media

Senate Bill (SB) 233 was authored in response to the Arizona Supreme Court’s decision on April 9 that an 1864 ban on abortion in the state is enforceable. The bill also aims to counter growing support for anti-abortion legislation in states with Republican-majority legislatures since Roe v. Wade was overturned, according to supporters.

“California will not sit idly by. We’re urgently moving legislation to allow Arizona doctors to provide safe and reliable reproductive care to Arizonans here in California,” Newsom said.

Sen. Nancy Skinner (D-Berkeley), chair of the California Legislative Women’s Caucus said that abortion bans are based on laws that set women back to a time when they had limited human rights.

“Anti-abortion forces have resurrected a dead law passed at a time when women couldn’t vote and husbands beating their wives was lawful,” Skinner said.

On April 24, the Arizona House of Representatives voted to repeal the 1864 abortion ban. It now moves to the Arizona Senate for deliberation.

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Mind, Body, and Spiritual Well-Being for Women Addressed in NAACP Forum in Oakland

The Women In The NAACP Oakland Branch is proud to announce the upcoming “Total You – Mind, Body, and Spirit Women’s Health Forum” scheduled for April 27 at Acts Full Gospel Church. Running from 9 a.m.-2 p.m. at 1034 66th Ave., this forum aims to provide an empowering platform for women to engage in discussions, gain knowledge, and access resources pertaining to their health and well-being.

Published

2 weeks ago

April 20, 2024

Oakland Post

The panel will address various aspects of women’s health, including physical, mental and emotional well-being and relationships. iStock photo by Jorge Elizaquibel.

Special to The Post

The Women In The NAACP Oakland Branch is proud to announce the upcoming “Total You – Mind, Body, and Spirit Women’s Health Forum” scheduled for April 27 at Acts Full Gospel Church.

Running from 9 a.m.-2 p.m. at 1034 66^th Ave., this forum aims to provide an empowering platform for women to engage in discussions, gain knowledge, and access resources pertaining to their health and well-being.

The forum will feature renowned experts, healthcare professionals, and advocates from Genentech, John Muir Health, Sutter Health of The East Bay, Kaiser Permanente, and the Alameda County Public Health Department.

Our expert panel will address various aspects of women’s health, including physical, mental, and emotional well-being, and healthy relationships. The forum will encompass a wide range of topics such as breast cancer, menopause, reproductive health, nutrition, mental health awareness, preventive care, and much more.

Participants will have the opportunity to attend informative sessions, interactive workshops, and panel discussions led by experts in their respective fields. Additionally, there will be wellness activities, screenings, and informational booths offering valuable resources and support.

This forum is open to women of all ages and backgrounds, encouraging inclusivity and diversity in the conversation surrounding women’s health. Whether you’re seeking information for yourself, a loved one, or simply looking to connect with other women, this event promises to be enlightening and empowering.

For more information and to register for the Total You Women’s Health Forum, please visit https://www.naacpoakland.org/ or contact Dr. Delores Thompson. WIN chairwoman at (510) 328-3638.

The Women In The NAACP Oakland Branch is dedicated to empowering women, and young teen girls. We look forward to your participation in this important event.

To register, go to https://www.naacpoakland.org/events/the-total-you-womens-health-forum