BridgeBio Pharma’s Beyonttra Secures European Approval, Challenging Pfizer’s Blockbuster Drug

Published: 25 Feb 2025

Author: Precedence Research

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The drug acoramidis is now made available by BridgeBio Pharma as a tactic to displace Pfizer's dominance in the cardiomyopathy treatment arm for transthyretin amyloidosis (ATTR), a completely new small-molecule TTR stabilizer. Following U.S. FDA approval in November 2024, the drug will be sold as Beyonttra. Acoramidis will have a market under it because it is approved by the European Commission in addition to the FDA.

ATTR is a progressive disorder whereby misfolded versions of the liver protein accumulate, resulting in a differential consequence on the nerve and heart. The Beyonttra drug introduced by BridgeBio aims to treat the cardiomyopathy associated with ATTR with better stabilization than Pfizer's Vyndaqel. Meanwhile, given that the Vyndaqel portfolio alone generated an impressive $3.3 billion in revenue in 2024, BridgeBio would thus be pitching Beyonttra as a formidable competitor against Vyndaqel.

Regulatory Milestones and Market Strategy

Just three short months after the U.S. FDA approved Beyonttra for the treatment of rheumatoid arthritis, Europe followed suit. It has a good uptake, with 1,028 unique patient prescriptions written by 516 prescribers. BridgeBio has entered into a commercialization agreement with Bayer in Europe, receiving milestone payments and royalties on sales across the continent. An initial milestone payment of $75 million is expected to be received upon European approval for the drug, which will enable BridgeBio to leverage the Bayer commercial infrastructure.

Competitive Landscape: Pfizer vs. BridgeBio

A biotech company, BridgeBio, seeks to introduce a treatment for the rare disease, ATTR cardiomyopathy. The gold standard treatment for the disease, Vyndaqel, manufactured by Pfizer, stabilizes TTR so as to inhibit the progression of the condition. BridgeBio, however, claims that Beyonttra would be able to provide superior stabilization, thus offering better outcomes to patients. The competition will be between real-world patient data and physician adoption. If Beyonttra proves to be more efficacious or has other benefits, like more convenient dosing, it could take on the market dominance of Pfizer. Pricing strategies would play a very important role in gaining market penetration, as will the regulatory approval in Europe - a significant part of the global expansion strategy of BridgeBio into Asia and Latin America.

Implications for the Biotech and Pharmaceutical Sectors

Approved in Europe, BridgeBio's Beyonttra is ready to take its stand as a competitor against the attr cardiomyopathy blockbuster drug introduced by Pfizer. With a partnership with Bayer, the firm seems to be having considerable grounds for commercial success in Europe although ongoing physician take-up in the U.S. has resulted in established confidence about its efficacy. Investors and industry analysts will closely track the enterprise's performance from both U.S. and Europe to ascertain its success in the long haul. The race for a lead in emerging indications becomes fiercer as the company shifts focus toward new geographies and treatments. The coming months will be critical to determining if Beyonttra can really shake up the market and reshape the competitive landscape for rare disease therapies