April 16, 2024

Medical Trend

Medical News and Medical Resources

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

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



 

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.

 

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

 

 

 

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.