Acoramidis

FDA approved BridgeBio Pharma’s Attruby for ATTR-CM treatment, aiming to reduce cardiovascular deaths and hospitalisations. The approval, based on a Phase III trial with 632 participants, triggers a $500m payment. Attruby showed significant benefits in trials, and BridgeBio plans global approvals. Trial participants in the US will receive Attruby free for life.

BridgeBio Pharma's BBIO stock rose after FDA approval of acoramidis for ATTR-CM treatment. Cassava Sciences' SAVA stock fell as simufilam failed in an Alzheimer's study. Amgen's AMGN shared positive 52-week data for MariTide in obesity, showing significant weight loss. Applied Therapeutics' APLT stock dropped after FDA's CRL for govorestat in galactosemia treatment.

Alnylam Pharmaceuticals' sNDA for Amvuttra (vutrisiran) to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM) has been accepted by the FDA under Priority Review, with a decision expected by March 23, 2025. Supported by positive phase III HELIOS-B study results, vutrisiran could become the first therapeutic approved in the U.S. for both hATTR polyneuropathy and ATTR-CM. Amvuttra sales significantly contribute to Alnylam's revenue, with potential for substantial growth upon approval.

BridgeBio Pharma's acoramidis, branded as Attruby, received FDA approval for treating transthyretin amyloidosis cardiomyopathy, leading to a 16.1% stock surge. Despite a 32.6% year-to-date loss, the approval, based on positive phase III results, positions Attruby as the first with near-complete TTR stabilization. It faces competition from Pfizer's Vyndaqel and Vyndamax.

FDA approved BridgeBio Pharma's Attruby for ATTR-CM, showing significant reduction in death and hospitalization in Phase 3 study. Attruby, the first with near-complete TTR stabilization, mimics a natural mutation, preserving TTR's function. BridgeBio plans European market entry by 2025, with Bayer handling commercialization. Stock rose 24.3% premarket.

November 2024 FDA updates include approval of VARIPULSE for atrial fibrillation, removal proposal for oral phenylephrine in nasal decongestants, CRL for Ocaliva in PBC, acceptance of pz-cel gene therapy BLA for RDEB, approval of Emrosi for rosacea, acceptance of dupilumab sBLA for CSU, CRL for IZERVAY in GA, Gildeuretinol for Stargardt disease receiving Rare Pediatric and Fast Track status, approval of bimekizumab for HS, acceptance of HLX14 biosimilar BLA for denosumab, approval of Attruby for ATTR-CM, and acceptance of vutrisiran sNDA for ATTR-CM.

Continuous use of acoramidis over 42 months significantly reduced risks of all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH) in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), according to data from the ATTRibute-CM trial and its open-label extension. The FDA approved acoramidis for ATTR-CM treatment, highlighting its efficacy in early diagnosis and prompt initiation of treatment.

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The FDA approved acoramidis (Attruby), developed at Stanford Medicine, for treating transthyretin amyloid cardiomyopathy (ATTR-CM). Originally AG10, it stabilizes transthyretin, preventing misfolding and aggregation in the heart, offering improved survival rates and quality of life for patients. The drug's development was supported by Stanford's SPARK program.

Avoid Attruby if allergic to its ingredients. Use only as prescribed by a healthcare provider, without sharing, cutting, or chewing. Inform your provider about health conditions, medications, pregnancy, or breastfeeding. For more info, visit www.attruby.com or call 844-550-2246.