Pfizer’s Vyndaqel will continue to dominate the field due to lack of competition

• Facebook
• Twitter
• Reddit
• Tumblr
• LinkedIn
• Pinterest
• RSS Feed
• Link

Pfizer’s Vyndaqel will continue to dominate the field due to lack of competition

• Red Yeast Rice Scare Grips Japan: Over 114 Hospitalized and 5 Deaths
• Long COVID Brain Fog: Blood-Brain Barrier Damage and Persistent Inflammation
• FDA has mandated a top-level black box warning for all marketed CAR-T therapies
• 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.