BAYER AG

FDA approves BridgeBio Pharma's Attruby (acoramidis) for ATTR-CM, reducing cardiovascular death and hospitalization. Based on ATTRibute-CM Phase 3 study, Attruby stabilizes TTR and improves quality of life. BridgeBio plans European launch with Bayer AG and offers free treatment to trial participants.

BridgeBio received FDA approval for Attruby (acoramidis), a near-complete TTR stabilizer for ATTR-CM, reducing cardiovascular death and hospitalization. Attruby, well-tolerated with mild side effects, significantly improved outcomes in the ATTRibute-CM Phase III study. BridgeBio will provide Attruby free for life to clinical trial participants and aims for global approvals.

FDA approves BridgeBio Pharma’s Attruby (acoramidis) for treating transthyretin amyloid cardiomyopathy (ATTR-CM), reducing cardiovascular death and hospitalisation. Attruby is the first approved drug targeting near-complete stabilisation of TTR, supported by positive ATTRibute-CM trial results. BridgeBio plans global approvals, with Bayer and AstraZeneca holding exclusive licenses in Europe and Japan, respectively.

FDA approves BridgeBio Pharma’s Attruby (acoramidis) for treating ATTR-CM, aiming to reduce cardiovascular deaths and hospitalisations. Attruby is the first with near-complete TTR stabilisation on its label, triggering a $500m payment to BridgeBio. The ATTRibute-CM Phase III trial, enrolling 632 subjects, met its primary endpoint with a win ratio of 1.8, showing significant treatment effects. BridgeBio plans global approvals, starting with Europe, Japan, and Brazil.

FDA approves BridgeBio Pharma's acoramidis (Attruby) for ATTR-CM, setting up a market competition with Pfizer's Vyndamax/Vyndaqel/Vynmac. Attruby, priced at $18,759 for a 28-day supply, aims to reduce cardiovascular death and hospitalization in ATTR-CM patients. BridgeBio plans to pursue regulatory approvals in Europe, Japan, and Brazil. Analysts predict potential peak sales of $2 billion or more for Attruby.

The global biopharmaceuticals market is projected to reach USD 566 billion by 2032, driven by innovations in treating previously untreatable diseases. North America led in 2022 with a 43% share. Key players like Pfizer and InflaRx are advancing therapies, but challenges include high costs and regulatory complexities. The industry is also focusing on sustainability and digital transformation.

Attruby, the first FDA-approved near-complete TTR stabilizer, significantly reduces cardiovascular death and hospitalizations in ATTR-CM patients, with rapid benefits seen in as few as 3 months. BridgeBio will provide Attruby free for life to U.S. clinical trial participants and offers extensive access programs. The company is set to receive $500 million under a royalty funding agreement and plans global expansion, with European approval expected in 2025.

BridgeBio Pharma's Attruby (acoramidis) approved by FDA for ATTR-CM, reducing cardiovascular death and hospitalization. Positive ATTRibute-CM Phase 3 results led to $500 million payment. European MAA submitted, with Bayer granted exclusive rights for commercialization.

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FDA approves BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy, priced at $244,000 annually. The drug stabilizes misfolded TTR protein, showing survival and hospitalization benefits. Market competition heats up with Pfizer's tafamidis and potential rivals. BridgeBio aims for 30% market share, planning head-to-head trials.