The AJMC® Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.
What We’re Reading: FDA Approves RSV Vaccine; Medicare to Cover Alzheimer Drugs; More States Extend Postpartum CoverageJune 1st 2023
The FDA approved Pfizer’s respiratory syncytial virus (RSV) vaccine Wednesday; Medicare announced plans to largely cover a new class of expensive Alzheimer drugs; more states are extending postpartum coverage under Medicaid.
Dr Christopher Cannon on Dual SGLT1/2 InhibitorsMay 27th 2023
Christopher P. Cannon, MD, a professor of medicine at Harvard Medical School and senior physician in the Cardiovascular Division at Brigham and Women’s Hospital, spoke about the benefit seen in a study of sotagliflozin for patients with acute heart failure.
What We’re Reading: COVID-19 Drug Approval; Thousands Lost Medicaid Coverage; Menstrual Cycles and CVD RiskMay 26th 2023
The FDA approves Pfizer’s oral COVID-19 drug; hundreds of thousands of people lose Medicaid coverage after pandemic protections expire; irregular menstrual cycles seem to be linked with higher cardiovascular disease (CVD) risks.
FDA Expands Dapagliflozin Label to Include Reducing Risk of CV Death in Heart FailureMay 9th 2023
Just over a year since AstraZeneca announced topline results, the FDA has approved a label expansion to include reducing cardiovascular (CV) death and heart failure–related hospitalizations for dapagliflozin (Farxiga) based on results of the phase 3 DELIVER trial.
FDA Approves Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial CarcinomaApril 5th 2023
The FDA has granted accelerated approval to enfortumab vedotin-ejfv plus pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
Pembrolizumab Receives Full Approval for Select Patients With MSI-H or dMMR Solid TumorsMarch 29th 2023
The FDA has granted full approval to pembrolizumab for the treatment of some patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) solid tumors that have progressed following previous treatment.
FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, HyrimozMarch 24th 2023
Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).
FDA Expands Abemaciclib Indication in HR+/HER2–, Node+, High-Risk Breast CancerMarch 7th 2023
The FDA approved an expanded indication for abemaciclib (Verzenio) in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)–positive, HER2-negative, node-positive, early breast cancer that is at a high risk of recurrence.
Pegcetacoplan Approval a “Dream Come True” for Patients With Geographic Atrophy, Says Dr Eleonora LadMarch 5th 2023
Pegcetacoplan was approved by the FDA to treat geographic atrophy (GA), providing a treatment option for patients who previously had none, explained Eleonora Lad, MD, PhD, associate professor of ophthalmology, Duke University.
FDA Approves Efanesoctocog Alfa for Hemophilia AFebruary 24th 2023
Efanesoctocog alfa is the first factor VIII therapy to overcome the interaction with endogenous von Willebrand factor, which creates a ceiling of 8 to 19 hours on the half-life of current factor VIII replacement products, which in turn creates the need for more frequent dosing.
FDA Approves Sacituzumab Govitecan for Pre-Treated HR+/HER2- Metastatic Breast CancerFebruary 3rd 2023
The approval is based on results from the phase 3 TROPiCS-02 trial demonstrating overall and progression survival benefits with sacituzumab govitecan compared with physician’s choice of single-agent chemotherapy.
FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell LymphomaJanuary 28th 2023
The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a previous Bruton tyrosine kinase (BTK) inhibitor.
FDA Approves Elacestrant for ER+/HER2–, ESR1-Mutated Advanced or Metastatic Breast CancerJanuary 27th 2023
The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.
Tucatinib Plus Trastuzumab Approved for RAS Wild-type, HER2+ Unresectable or Metastatic CRCJanuary 19th 2023
The combination of tucatinib and trastuzumab received accelerated approval from the FDA to treat adults with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer (mCRC) that advances after treatment with specific types of chemotherapy.
FDA’s Lecanemab Approval Will Raise Pricing, Access Challenges, Says Dr Alvaro Pascual-LeoneJanuary 6th 2023
The FDA’s approval of lecanemab for Alzheimer disease is very important, but there will remain significant challenges around pricing and access that will need to be addressed to deliver on the promise the therapy actually represents, said Alvaro Pascual-Leone, MD, PhD, of Harvard Medical School.
FDA Approves Lecanemab to Treat Early Alzheimer DiseaseJanuary 6th 2023
The lecanemab decision follows the controversial 2021 approval of aducanumab, which led to tight coverage restrictions for monoclonal antibodies directed against amyloid for the treatment of Alzheimer disease.