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