The Food and Drug Administration’s (FDA) drug review arm has proposed withdrawing approval for Amgen Inc.’s (NASDAQ:AMGN) Tavneos (avacopan), citing concerns over data integrity, lack of proven effectiveness, and misleading statements in its application.
Amgen added Tavneos to its portfolio via the ChemoCentryx deal in 2022 for $52 per share in cash, representing an enterprise value of approximately $3.7 billion.
FDA Flags Data Integrity Issues
The Center for Drug Evaluation and Research (CDER) said new information revealed that key data supporting Tavneos’ approval was manipulated.
The agency found that unblinded study personnel altered endpoint results in the Phase 3 ADVOCATE trial, the sole study used to establish the drug’s effectiveness.
In a letter to the company, CDER highlighted that manipulation changed outcomes that were not statistically significant, making the drug appear effective.
The original analysis, conducted under a prespecified statistical plan, did not support approval. Regulators noted that this data was not submitted as required, raising concerns over compliance with clinical reporting standards.
Lack Of Substantial Evidence
Based on the newly uncovered information, CDER concluded that Tavneos lacks substantial evidence of effectiveness under its labeled conditions of use.
When evaluated alongside the original dataset available at the time of approval, the revised findings failed to meet regulatory thresholds. CDER said this deficiency alone justifies withdrawing the drug’s approval.
Tavneos, approved in October 2021, is used in combination with glucocorticoids and other therapies to treat adults with severe active ANCA-associated vasculitis, a rare autoimmune condition affecting small- to medium-sized blood vessels.
In March, the FDA warned patients and healthcare providers about serious and sometimes fatal liver injuries tied to Tavneos, citing postmarketing data that point to new safety concerns beyond those identified in clinical trials.
The agency said cases of drug-induced liver injury (DILI), including a rare but severe condition known as vanishing bile duct syndrome (VBDS), have been reported in patients treated with Tavneos.
AMGN Stock Price Activity: Amgen shares were down 0.30% at $339.17 at the time of publication on Tuesday, according to Benzinga Pro data.
Photo via Amgen
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