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There’s a rare heart condition known as transthyretin amyloidosis cardiomyopathy that has caught the attention of drug developers. Pfizer already has an approved treatment, and two other companies, BridgeBio Pharma and Alnylam Pharmaceuticals, have promising drugs that have passed late-stage trials. The decision on which drug is most beneficial is crucial because the market is worth billions. The FDA is expected to decide on BridgeBio’s drug, acoramidis, by Thanksgiving. This could start a new phase in the debate about the best treatment option. The FDA is also reviewing new drugs from AstraZeneca, Vertex Pharmaceuticals, Bristol Myers Squibb, and PTC Therapeutics.
1. **BridgeBio’s Acoramidis for Heart Disease**: BridgeBio Pharma rebounded after initial trial results weren’t promising. Their drug acoramidis could soon join Pfizer’s Vyndamax in the market if approved. It aims to prevent a protein from misfolding, which is thought to help with the disease.
2. **AstraZeneca and Daiichi Sankyo’s Lung Cancer Drug**: These companies are awaiting FDA approval for a new lung cancer treatment called dato-dxd, similar to their successful breast cancer drug, Enhertu. While it delays tumor growth, it hasn’t shown a significant survival benefit.
3. **Vertex’s New Cystic Fibrosis Treatment**: Vertex Pharmaceuticals is hoping to expand its cystic fibrosis treatments with a new drug regimen called “vanza triple,” which could offer the convenience of once-daily dosing and longer patent protection.
4. **PTC’s Gene Therapy for a Rare Disorder**: PTC Therapeutics is seeking FDA approval for Upstaza, a gene therapy for a rare nervous system disorder. It’s already approved in Europe, but the process has been slower in the U.S.
5. **Bristol Myers’ New Version of Opdivo for Cancer**: Bristol Myers aims to protect its revenue by introducing a new, more convenient version of its cancer drug Opdivo, which could be approved by the end of the year. This version is given as an injection under the skin rather than an infusion.
These decisions from the FDA are important to watch as they could lead to new treatments and impact the companies financially.