Product Approvals and Launches

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.

Olaparib plus abiraterone and prednisone or prednisolone already is approved in the European Union and several other countries.

Lexicon Pharmaceuticals received approval for sotagliflozin to treat a broad range of left ventricular ejection fraction, for patients with and without diabetes.

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.

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.

The FDA approved Celltrion Healthcare’s Yuflyma (adalimumab-aaty), which is a high-concentration, citrate-free formulation.

Approval for the T-cell–engaging bispecific antibody came today from the FDA.

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.

A vaccine for adults 60 years and older was approved by the FDA for protection against respiratory syncytial virus, making it the first such vaccine to be approved worldwide.

The FDA has approved polatuzumab vedotin-piiq plus rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for certain patients with treatment-naive diffuse large B-cell lymphoma.

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.

Data from the PANORAMA-HF and PARADIGM-HF trials support the recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

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.

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).

Sarilumab, a biologic, is sold as Kevzara.

The FDA approved the VENTANA PD-L1 assay for expanded use in patients with advanced non–small-cell lung cancer to help identify patients who may be candidates for treatment with cemiplimab.

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 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.

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.

Geographic atrophy is a leading cause of blindness. The new approval will help to fill an unmet need for patients.

Daprodustat (Jesduvroq, GSK) is the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor to gain approval in the United States.

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.

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.

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.

The broad approval, while expected, will likely signal a milestone in the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

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.

Ublituximab-xiiy, developed by TG Therapeutics, will be sold under the name Briumvi.

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.

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.