Health

FDA Panel Backs First-in-Class Cholesterol Drug

Published

9 years ago

June 10, 2015

Oakland Post

Sanofi Aventis (AP Photo)

MATTHEW PERRONE, AP Health Writer

GAITHERSBURG, Md. (AP) — Federal health advisers on Tuesday recommended approval for a highly anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.

The expert panel recommended by a 13-3 vote that the Food and Drug Administration approve the injectable drug, called Praluent.

But in an unexpected development, a number of panelists said the drug should only be used in patients with abnormally high cholesterol levels caused by an inherited disorder. Those panelists said they wanted to see more data about whether the drug ultimately reduces heart problems, before it is used more broadly.

“I personally fall on the side of having optimism, but I need to see the cardiovascular outcome study to know,” said Dr. Philip Sanger of Stanford University, who voted for the drug.

If the FDA follows the group’s recommendation, the drug could be approved for a much smaller population than its developers have proposed.

Praluent is part of a new class of injectable drugs that lower cholesterol more than older medications called statins, which have been the standard treatment for more than 20 years. A similar drug from Amgen will go before the same panel on Wednesday.

Both drugs block a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood. Analysts expect the drugs to grow into blockbuster sellers, generating billions of dollars in new sales. But Tuesday’s meeting underscores the uncertainty about who should receive such medications.

More than 73 million U.S. adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease, the leading cause of death in the U.S.

Paris-based Sanofi and Regeneron, which is based in Tarrytown, New York, have suggested marketing their drug to a large group of patients, including those who are at high-risk for heart attacks and those who cannot tolerate statin drugs due to side effects.

But many panelists said they would limit the drug’s use to a much narrower group of patients who have abnormally high cholesterol levels caused by a family disorder.

“I am really only comfortable with the risk-benefit equation in that population,” said Michele Orzsa, the panel’s consumer representative.

Key to the panel’s decision was whether lowering bad, or LDL, cholesterol translates into reduced heart attacks. For over 20 years, the FDA has used reduced LDL levels as a benchmark to approve cholesterol drugs, including statins like Lipitor and Zocor.

But recent studies of drugs like niacin have shown that reducing cholesterol levels does not always lead to reductions in heart attack, stroke and related problems.

The FDA’s internal scientists pressed panelists on whether they thought lower LDL cholesterol was still an accurate predictor of a drug’s benefit.

“I don’t believe we have enough data today to say that LDL, with a new drug class, is sufficient for approval,” said Dr. William Hiatt, of the University of Colorado’s School of Medicine, who voted against the drug.

Despite the measured endorsement, company representatives said they were “gratified” by the meeting’s outcome.

“This is one of the next big milestones for this product and the promise it can deliver to patients,” Bill Sasiela, a vice president with Regeneron Pharmaceuticals Inc.

Regeneron’s stock fell about 3 percent in extended trading following the announcement. Sanofi’s U.S.-traded shares rose about 1 percent.

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LIVE! — TOWN HALL ON RACISM AND ITS IMPACT — THURS. 11.14.24 5PM PST

Join us for a LIVE Virtual Town Hall on the Impact of Racism hosted by Post News Group Journalist Carla Thomas and featuring Oakland, CA NAACP President Cynthia Adams & other Special Guests.
Thursday, November 14, 2024, 5 p.m. – 6:30 p.m. PST

Published

2 weeks ago

November 12, 2024

Oakland Post

Discussion Topics:
• Since the pandemic, what battles have the NAACP fought nationally, and how have they impacted us locally?
• What trends are you seeing concerning Racism? Is it more covert or overt?
• What are the top 5 issues resulting from racism in our communities?
• How do racial and other types of discrimination impact local communities?
• What are the most effective ways our community can combat racism and hate?

Your questions and comments will be shared LIVE with the moderators and viewers during the broadcast.

STREAMED LIVE!
FACEBOOK: facebook.com/PostNewsGroup
YOUTUBE: youtube.com/blackpressusatv
X: twitter.com/blackpressusa

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California Black Media

Gen. Election Update: Tracking Your Votes on Ballot Propositions — and What They Mean for Our Communities

In the Nov. 5 General Election, Californians cast their votes on ten propositions addressing issues from education and climate funding to prison labor and the minimum wage.

Published

3 weeks ago

November 6, 2024

Oakland Post

By Joe W. Bowers Jr., California Black Media

In the Nov. 5 General Election, Californians cast their votes on ten propositions addressing issues from education and climate funding to prison labor and the minimum wage.

Below is a breakdown of the propositions, their potential impact and an update on how we voted on them.

Likely to Pass:

Proposition 2: Bonds for Public School and College Facilities
With 56.7% support, Prop 2 is on track to pass. This measure would allocate $10 billion to repair and upgrade K-12 and community college facilities, especially in under-resourced schools. For students, this funding could lead to safer and more supportive learning environments.

Proposition 3: Constitutional Right to Marriage
Prop 3 currently has 61.4% support and is likely to pass. This measure aims to amend California’s constitution to affirm marriage rights for all. For LGBTQ+ individuals in our communities, this is a powerful affirmation of equality and inclusion.

Proposition 4: Bonds for Water, Wildfire, and Climate Risks
Currently passing with 57.8%, Prop 4 is on track to deliver $10 billion for projects that address water quality, wildfire prevention, and climate resilience. This could have a significant impact on communities that face the harshest effects of climate change.

Proposition 34: Restricts Spending of Prescription Revenues
Prop 34 is narrowly passing with 51.4% support, indicating that it may succeed. The measure would require specific healthcare providers to use 98% of revenue from federal drug discount programs on direct patient care. This could improve healthcare access for low-income residents.

Proposition 35: Provides Permanent Funding for Medi-Cal
With 66.8% of voters in favor, Prop 35 is on course to pass, securing permanent funding for Medi-Cal, California’s low-income healthcare program. For many in our communities who depend on Medi-Cal, this measure promises stability and continued access to essential healthcare services.

Proposition 36: Increased Sentencing for Certain Drug and Theft Crimes
With strong support at 70.5%, Prop 36 is poised to pass, increasing penalties for specific theft and drug offenses. This measure would partially roll back sentence reductions established by Prop 47, sparking concerns about potential increases in incarceration rates.

Likely to Fail:

Proposition 5: Bonds for Affordable Housing and Infrastructure
With 56.4% of voters opposed, Prop 5 is likely to fail. The measure aimed to reduce the voting threshold for local bonds from two-thirds to 55%, making it easier to fund affordable housing. Without it, local governments will continue to face higher approval requirements, potentially slowing progress on affordable housing solutions.

Proposition 6: Eliminates Forcing Inmates to Work
Currently failing with 54.9% opposed, Prop 6 is expected to be defeated. This measure would have ended involuntary labor for incarcerated individuals, a practice critics argue disproportionately affects Black inmates. It’s likely failure means the prison labor system will remain unchanged.

Proposition 32: Raises Minimum Wage
With 52.1% of voters opposing it, Prop 32 appears likely to fail. This measure would have raised the minimum wage to $18 an hour. While proponents argued it would provide greater financial stability for low-wage workers.

Proposition 33: Local Government Residential Rent Control
With 61.9% voting “no,” Prop 33 is expected to fail, meaning that local governments won’t gain expanded authority to enact rent control. Real estate groups argued that this measure could hinder housing development. Its failure means that current rent control laws will remain in place, leaving fewer protections for renters.

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California Black Media

Covered California Open Enrollment Began Nov. 1

Open enrollment for Covered California kicked off on Nov. 1, 2024, offering individuals, families, and businesses a chance to secure quality, affordable health insurance for the upcoming year. This annual enrollment period allows California residents to choose from a variety of health plans that meet their specific needs. Covered California offers comprehensive coverage, including preventive care and financial assistance to help eligible applicants lower their monthly premiums.

Published

3 weeks ago

November 6, 2024

Oakland Post

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By Bo Tefu, California Black Media

Covered California offers comprehensive coverage, including preventive care and financial assistance to help eligible applicants lower their monthly premiums. The program features insurance plans from leading providers, ensuring access to essential health services such as doctor visits, hospital care, and mental health services.

This year, notable updates include expanded financial assistance, which increases the support available for eligible households to help offset monthly costs. Additionally, consumers will find greater plan flexibility, allowing them to select options that fit their lifestyles and budgets. Access to no-cost preventive services — like vaccinations, screenings, and annual check-ups — remains a priority.

Key enrollment deadlines are set as follows:

The open enrollment period runs from Nov. 1, 2024, to Jan. 31, 2025.
Those who enroll by Dec. 15, 2024, will have their coverage start on Jan. 1, 2025.

To facilitate enrollment, applicants can fill out an inquiry form on the Covered California website, reach out to Certified Enrollment Counselors, or contact Covered California directly at (888) 234-5366 or via email at GetCovered@cbhn.info.

The California Black Health Network (CBHN) collaborates with Covered California to advocate for health equity, focusing on underserved communities, including unemployed and gig workers. CBHN’s certified enrollers engage in outreach and onsite signups to help individuals access affordable healthcare options.