- Center on Health Equity and Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
FDA Panel Gives Evolocumab Green Light, With Advice on Who Gets It to Follow
FDA's advisory panel voted 11-4 to give the green light to Amgen's entrant in the PCSK9 inhibitor race, but not after a lengthy discussion on who should get the drug.
An FDA advisory panel voted 11-4 Wednesday to recommend approval for Amgen’s PCSK9 evolocumab, but not without a lengthy discussion of which patients would be eligible to receive the drug. More advice on those terms is expected.
Similar caveats were seen in Tuesday’s 13-3 advisory panel vote to recommend alirocumab, from Sanofi-Regeneron. Both PCSK9 inhibitors facing deadlines this summer for FDA action.
The advisory panel votes have the potential to take huge markets for the drug off the table. But for anyone following editorials in leading journals, the ambivalence shouldn’t have come as a surprise.
FDA’s 16-member Endocrinologic and Metabolic Drugs Advisory Committee (which changed slightly from Tuesday to Wednesday) only had to find that the drugs’ manufacturers had established that the LDL cholesterol—lowering benefit for certain populations. But who those populations will be was the subject of much debate. After Tuesday’s discussion, Amgen brought in Marc Sabatine, MD, who had presented results on evolocumab at the recent meeting of the American College of Cardiology on why patients who cannot tolerate statins should have access to the therapy.
For more read:
Real-World Study Reveals Key Insights into DLBCL Treatment Patterns, Outcomes
April 18th 2024A recent study offers valuable insights into the characteristics, treatment patterns, and outcomes of diffuse large B-cell lymphoma (DLBCL) in patients across different lines of therapy, providing a look into the landscape of DLBCL management.
Read More
Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
Listen
Gene, Light Therapy Combo Shows Promise Against Prostate Cancer Cells in Proof-of-Concept Study
April 18th 2024In their preclinical model, the researchers found efficacy both in vitro and in vivo by using CRISPR-Cas9 to mimic porphyria and combining the technology with light therapy.
Read More
Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
Listen
Collecting SDOH Data Can Assess Risk of Medical Nonadherence, Improve HEI and Star Ratings
April 18th 2024At the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting, a panel of presenters explored changes coming to Medicare that incorporate social determinants of health (SDOH) data to improve patient and health system outcomes.
Read More
