Acoramidis

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EMA's CHMP recommended 17 drugs for market authorization in Dec 2024, including 5 orphan drugs and 6 biosimilars. Notable recommendations include Kavigale for COVID-19 prevention in immunocompromised individuals and Kostaive, a mRNA vaccine for COVID-19 prevention. CHMP also extended recommendations for several drugs and withdrew Alofisel from the market.

The CHMP recommended acoramidis, an oral TTR stabilizer, for EU marketing authorization in adult ATTR-CM patients. Acoramidis demonstrated near-complete TTR stabilization and benefits on cardiovascular endpoints in the ATTRibute-CM study. The CHMP's positive opinion offers hope for ATTR-CM patients, with a final EU decision expected soon.

Acoramidis, a TTR stabilizer, shows efficacy in ATTR-CM patients by reducing all-cause mortality and cardiovascular hospitalizations. It achieves near-complete TTR stabilization by Day 28, with significant improvements in functional capacity and health status by Month 30. Pharmacokinetics indicate rapid absorption, protein binding, and metabolism, with steady state achieved in 4 days.

The CHMP recommended acoramidis, an orally administered TTR stabilizer, for EU marketing authorization in adult patients with ATTR-CM. Acoramidis demonstrated near-complete TTR stabilization and benefits on cardiovascular endpoints in the Phase III ATTRibute-CM study. The CHMP's positive opinion offers hope for ATTR-CM patients, with the European Commission's final decision expected soon. Bayer plans to launch acoramidis in Europe in the first half of 2025.

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Bayer AG gains EU regulator backing for acoramidis, an oral medicine treating transthyretin amyloidosis in cardiomyopathy patients. Acquired from BridgeBio Pharma for $310M, it aims to offset expiring patents of top-selling drugs. Approved by the FDA, Bayer plans to launch in Europe by H1 2025.

CHMP recommends EU approval for acoramidis, a TTR stabilizer, based on Phase 3 ATTRibute-CM study results showing reduced cardiovascular events. FDA approved it as Attruby in the U.S. for ATTR-CM. Final EU decision expected soon, with Bayer planning a 2025 launch in Europe.

Bayer likely to launch heart drug Acoramidis in EU soon, CHMP recommends approval based on Phase III results. The drug treats ATTR-CM, showing positive impact on cardiovascular endpoints. Bayer acquired European marketing rights in March. Analysts estimate peak sales at EUR 260 million by 2030, aiding in offsetting declining sales of Xarelto.