Pfizer’s Vyndaqel will continue to dominate the field due to lack of competition
- Japan: Deaths Linked to Red Yeast Rice Supplement Increased to 5
- Omalizumab Offers Protection Against Accidental Allergic Reactions in Children
- A single shot that rejuvenates the immune system
- The Rise of Immunocell Therapy and the Era of “Farewell to Chemotherapy”
- Second Death Linked to Red Yeast Rice Supplement Reported in Japan
- Why Was Dementia Almost Nonexistent in Ancient Greece and Rome?
Pfizer’s Vyndaqel will continue to dominate the field due to lack of competition
- Long COVID Brain Fog: Blood-Brain Barrier Damage and Persistent Inflammation
- Japan: Over 10,000 Applications for Health Damage from COVID-19 Vaccines
- FDA has mandated a top-level black box warning for all marketed CAR-T therapies
- ‘Elixir of Immortality’ Nicotinamide Riboside (NR) Virtually No Effect
- Can people with high blood pressure eat peanuts?
- What is the difference between dopamine and dobutamine?
- How long can the patient live after heart stent surgery?
Pfizer’s Vyndaqel will continue to dominate the field due to lack of competition.
On February 21 , Alnylam , the world’s leading RNAi therapeutics company , announced that the U.S. Food and Drug Administration ( FDA ) has accepted the Supplemental New Drug Application ( sNDA ) for Onpattro ( patisiran ) for the treatment of transthyretin-mediated ( ATTR ) amyloid cardiomyopathy ).
The FDA has set a Prescription Drug User Fee Act ( PDUFA ) date of October 8 , 2023 . Onpattro is currently FDA -approved for the treatment of polyneuropathy in adults with hereditary ATTR amyloidosis .
However, the FDA plans to hold an expert advisory committee meeting to discuss the application.
Given the controversial clinical data for Onpattro in ATTR-CM , the FDA’s announcement of an advisory committee meeting was not a surprise.
It follows a phase III trial called APOLLO-B that met its primary endpoint, with Onpattro showing a clear benefit over placebo in measuring functional decline in patients measured by a 6 -minute walk test. But a subgroup analysis found little improvement among patients who had received Pfizer’s Vyndaqel/Vyndamax ( tafamidis ).
What’s more, on the secondary endpoint, Onpattro failed to achieve statistically significant gains compared with placebo in the key outcomes evaluating all-cause death, cardiovascular events and change in the six-minute walk test after 12 months Significant benefit.
ATTR-CM is currently an area dominated by Pfizer’s blockbuster products . Vyndaqel/Vyndamax will bring Pfizer $2.447 billion in revenue in 2022 , a year-on-year increase of 21%.
Alnylam ‘s Onpattro needs to meet a high bar if it’s going to challenge Pfizer’s Vyndaqel , including showing significant add-on benefits to Pfizer’s drug. It now appears that even if Onpattro is approved, it lacks a clear advantage over Vyndaqel/Vyndamax .
Onpattro ‘s ATTR-CM indication isn’t the most important part of Alnylam’s business. All eyes are now on another ATTR-CM phase III HELIOS-B trial of the company’s second-generation RNAi therapy , Amvuttra , with data expected in early 2024 .
Pfizer’s Vyndaqel will continue to dominate the field due to lack of competition.
(source:internet, reference only)
Disclaimer of medicaltrend.org
Important Note: The information provided is for informational purposes only and should not be considered as medical advice.