Insights+: The US FDA New Drug Approvals in May 2024
Shots:
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PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2024
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The US FDA approved a total of 3 new drugs including 2 new molecular entities and 1 biologic leading to treatments for patients and advances in the healthcare industry
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The major highlighted drug was Amgen’s Imdelltra for the treatment of ES-SCLC
Active Ingredient: Mycophenolate mofetil
Approved: May 01, 2024
Company: Azurity Pharmaceuticals
Disease: Organ Rejection
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The US FDA has approved Azurity Pharmaceuticals’ Myhibbin oral suspension with its commercial availability anticipated in Q2’24
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Myhibbin in addition to other immunosuppressants is intended for preventing organ rejection in adults & pediatric patients (age: ≥3mos.) of allogeneic kidney, heart, or liver transplant
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Mycophenolate mofetil, an antimetabolite immunosuppressant, works on the immune system of the body to prevent organ rejection
Active Ingredient: Tarlatamab-dlle
Approved: May 16, 2024
Company: Amgen
Disease: Extensive-Stage Small Cell Lung Cancer
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The US FDA has granted accelerated approval to Amgen’s Imdelltra (DLL3-targeting bispecific T-cell engager) for treating extensive-stage small cell lung cancer (ES-SCLC) adults whose disease progressed post Pt-based CT. Full approval depends upon confirmatory trials
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The approval was based on the P-II (DeLLphi-301) study assessing Imdelltra (10mg, Q2W) in SCLC patients (n=99) failing on 2 or more previous lines of treatment & administered with the 10mg Q2W dosing regimen
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The results depicted an ORR of 40%, mDoR of 9.7mos. and mOS of 14.3mos. Further evaluation continues for complete survival data
Active Ingredient: Clonidine hydrochloride
Approved: May 24, 2024
Company: Tris Pharma
Disease: Attention Deficit Hyperactivity Disorder
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The US FDA has granted approval to the company’s QD extended-release oral suspension of Onyda XR (clonidine hydrochloride) with nighttime dosing alone or as adj. to approved central nervous system (CNS) stimulant therapies for ADHD treatment in children (≥6yrs.). Its availability is anticipated in H2’24
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The approval was supported by the data from studies evaluating clonidine hydrochloride extended-release tablets
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Onyda XR is the first non-stimulant ADHD medication that has been developed using the company’s LiquiXR technology for treating ADHD
Related Post: Insights+: The US FDA New Drug Approvals in April 2024
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com