The FDA does not recommend Mounjaro for people with personal or family history of medullary thyroid cancer, or who have multiple endocrine neoplasia syndrome type 2. The drug was shown to cause thyroid C-cell tumors in rats, and it is unknown whether it can cause such tumors or cancers in ...
The "Twincretin" era for treating patients with type 2 diabetes has begun, with the US Food and Drug Administration's (FDA's) approval of tirzepatide for this indication on May 13, making it the first approved agent that works as a dual agonist for the two principal human incretins. ...
today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” said Dr. Patrick Archdeacon, associate director of the FDA's Division of Diabetes, Lipid Disorders, and Obesity, in a press release.
2022年5月13日,来自美国食品和药物管理局(FDA)官网的消息。 同类首款(first-in-class)葡萄糖依赖性促胰岛素多肽(GIP)和胰高糖素样肽-1(GLP-1)双重受体激动剂——tirzepatide(商品名:Mounjaro),获美国FDA批准上市。 FDA批准其作为饮食和运动的补充,用于改善成人2型糖尿病患者的血糖控制。 来源:FDA官网 “考虑...
While Mounjaro had already been used by some patients "off-label" for weight loss, the new FDA approval will allow the drugmaker to begin officially selling and marketing tirzepatide — branded as Zepbound — for weight loss too. Zepbound will be available for patients in the U.S. by ...
The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes given the results seen in these clinical trials," SURPASS program investigator Juan Pablo Frías, MD, medical director, National Research Institute, said in a press release. References 1. FDA approves ...
Tirzepatide is already approved under the brand name Mounjaro (Lilly) to be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes. The FDA has approved tirzepatide (Zepbound; Eli Lilly and Co) injection for chronic weight management in adults with obesity...
与Wegovy相比,最近批准的减肥新药Zepbound的用于治疗2型糖尿病的版本Mounjaro的类似试验可能会在今年晚些时候得出结果,而Zepbound的类似试验可能会在几年后进行。 另外值得注意的是,这一适应症的批准可能有助于保险的覆盖。在美国,一些保险公司不愿为Wegovy和其他治疗肥胖症的胰高血糖素样肽-1激动剂药物提供承保,认为...
1.FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease;sanofi官网 2.丙酮酸激酶缺乏症(PKD)疾病修正疗法!美国FDA批准首创口服PK变构激活剂Pyrukynd(mitapivat)!生物谷 3.Novel Drug Appr...
Mounjaro可以说是近10年来降糖药的新代表。它通过同时激活GIP与GLP-1受体来改善血糖的控制。此外,Mounjaro的给药方式也很特别——采用礼来专利的自动注射器装置,可以实现患者视觉上的“无”针头化给药。 银屑病作为一种难治皮肤病,今年有多款治疗药物上线。5月,FDA正式批准Roivant旗下Dermavant开发的Vtama乳膏上市...