Tirzepatide for Obesity, Ixchiq Chikungunya Vaccine, fruquintinib for mCRC, Adzynma (ADAMTS13, recombinant-krhn) for cTTP

New FDA Approvals

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Here are the highlights:

• The FDA has approved Zepbound (tirzepatide) for adults with obesity, allowing its use in individuals with a body mass index (BMI) of 30 or more, as well as overweight individuals (BMI of 27 or greater) with at least one weight-related condition. Tirzepatide, an agonist of GLP-1 and GIP, was shown to significantly reduce body weight when used in combination with a reduced-calorie diet and increased physical activity in clinical trials, but it may have adverse effects, including gastrointestinal issues and a potential link to medullary thyroid cancer.
• Ixchiq has become the first FDA-approved chikungunya vaccine for individuals aged 18 and older at increased risk of exposure to the chikungunya virus, which is primarily transmitted by mosquitoes. Chikungunya is a global health threat with symptoms including fever, joint pain, and rash, and severe joint pain that can last for months. The vaccine, while effective, may cause severe or prolonged chikungunya-like adverse reactions, and the manufacturer, Valneva, is required to conduct a postmarketing study to assess these risks.
• Fruzaqla (fruquintinib) has received FDA approval for patients with metastatic colorectal cancer (mCRC) who have undergone previous treatments, including various chemotherapy and targeted therapies. Fruquintinib, a kinase inhibitor of VEGFRs, demonstrated improvements in overall survival and progression-free survival in clinical trials, with consistent safety profiles. The approval was granted to Takeda, and the drug is also under review for marketing authorization in Europe.
• Adzynma (ADAMTS13, recombinant-krhn) has been approved by the FDA for congenital thrombotic thrombocytopenic purpura (cTTP), making it the first FDA-approved recombinant ADAMTS13 protein for this rare condition. cTTP results from a deficiency in ADAMTS13, leading to blood clot formation and severe bleeding episodes. Adzynma serves as prophylactic and on-demand treatment, with promising results in a phase 3 study, and its approval was granted to Takeda.

Intro and outro music

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