Here is information on the latest US FDA approvals, the week of November 6 – November 10, 2023
Tirzepatide (Zepbound) for Adults With Obesity
The FDA has approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body mass index of 30 kg/ m2 or more. It’s also approved for overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol. Tirzepatide is to be used in addition to a reduced calorie diet and increased physical activity. Tirzepatide is already indicated under the trade name Mounjaro in adults with type 2 diabetes mellitus. Tirzepatide is an agonist of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), activity that helps to delay gastric emptying and reduce appetite and food intake. Tirzepatide was evaluated in combination with a reduced-calorie diet and increased physical activity in two randomized trials. In both trials, after 72 weeks of treatment, patients who received tirzepatide at all three dose levels experienced a statistically significant reduction in body weight compared to those who received placebo, and greater proportions of patients who received tirzepatide achieved at least 5% weight reduction compared to placebo. The larger of the two trials enrolled adults without diabetes and participants lost on average 18% of their body weight compared to those randomized to placebo. Adverse events include nausea, diarrhea, and other gastrointestinal conditions. Tirzepatide may be linked to an increased risk of medullary thyroid cancer in humans. The FDA granted this approval to the manufacturer Eli Lilly and Co.
https://pi.lilly.com/us/zepbound-uspi.pdf?s=pi
Ixchiq, the First Chikungunya Vaccine
The FDA has approved Ixchiq, the first chikungunya vaccine for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has recently spread to new geographical areas causing a rise in global prevalence of the disease. Common symptoms of chikungunya include fever, joint pain, rash, headache, and muscle pain. Debilitating joint pain with this infection may persist for months or years. The Prescribing Information includes a warning to inform that the vaccine may cause severe or prolonged chikungunya-like adverse reactions. The FDA is requiring the Austrian manufacturer, Valneva, to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of Ixchiq.
Fruzaqla (fruquintinib) for mCRC
The FDA has approved Fruzaqla (fruquintinib) for patients with metastatic colorectal cancer (mCRC) who have undergone previous treatment. The oral therapy is indicated for patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. Fruquintinib is a small molecule kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3. The FDA based its approval on two Phase 3 trials – the international FRESCO-2 study and the China-based FRESCO study. The trials compared previously treated mCRC patients who received Fruquintinib plus best supportive care compared to previously treated mCRC patients who received placebo plus best supportive care. Results from FRESCO-2 demonstrated improvement in overall survival and progression-free survival, meeting its primary and secondary endpoints. The FRESCO trial also met its efficacy endpoints. Both trials showed consistent safety. This week’s approval was granted to Takeda. Fruquintinib was approved for use in China in September 2018, where it is sold under the brand name Elunate. The drug is currently under review for marketing authorization by the European Medicines Agency (EMA).
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217564s000lbl.pdf
Adzynma (ADAMTS13, recombinant-krhn) for cTTP
The FDA has approved Adzynma (ADAMTS13, recombinant-krhn) for congenital thrombotic thrombocytopenic purpura (cTTP). The indication is for prophylactic and on-demand treatment of adult and pediatric patients and makes this agent the first and only FDA-approved recombinant ADAMTS13 (rADAMTS13) protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme. cTTP results from a mutation in the gene that codes for ADAMTS13, an enzyme that regulates blood clotting. Without enough of this enzyme, blood clots form in small blood vessels throughout the body. Those clots lead to severe bleeding episodes, strokes, and organ damage. cTTP is estimated to affect fewer than 1,000 people in the US. Current cTTP treatment involves prophylactic plasma-based therapy, which replenishes deficient ADAMTS13 with the goal of reducing the risk of clotting and bleeding problems. In a phase 3 open-label crossover study none of the patients experienced an acute clotting event while receiving Adzynma. There was one event reported in a patient while receiving plasma-based therapy. The approval was granted to Takeda. https://www.fda.gov/media/173756/download
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