Product Approvals and Launches

Nipocalimab (Imaavy; Johnson & Johnson), an FcRn-blocking monoclonal antibody, was approved for patients 12 years and older with generalized myasthenia gravis based on data from the ongoing Vivacity-MG3 study.

Prademagene zamikeracel (Zevaskyn) is the first and only cell-based gene therapy for wound treatment in patients with recessive dystrophic epidermolysis bullosa.

The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the duration is not approved.

Marking the first approval in over a decade for this challenging condition, the FDA has approved dupilumab (Dupixent) to treat chronic spontaneous urticaria in patients 12 years and older whose hives and itching remain uncontrolled by antihistamines.

The combination therapy can be used as first-line treatment for unresectable or metastatic forms of the cancer.

Richard Lafayette, MD, FACP, Stanford University Medical Center, explains the significance of this second approval in a month for proteinuria reduction.

ECHELON-3 (NCT04404283) principal investigator Craig A. Portell, MD, speaks to the significance of this triplet approval from February as an alternative to more complex and time-consuming regimens in the setting of relapsed/refractory large B-cell lymphoma (R/R LBCL).

Carla Nester, MD, MSA, FASN, is coinvestigator for the ongoing APPEAR-C3G trial (NCT04817618), data from which were used to support the FDA’s recent approval of iptacopan (Fabhalta; Novartis) in complement 3 glomerulopathy (C3G).

Inebilizumab-cdon (Uplizna; Amgen) was approved as the first and only treatment for immunoglobulin G4–related disease (IgG4-RD), a chronic and debilitating immune-mediated inflammatory condition.

Astrasentan becomes the first and only endothelin A receptor antagonist to focus on proteinuria reduction in primary immunoglobulin A (IgA) nephropathy.

The topical ocular drug is an investigational new drug candidate that requires more well-controlled studies to establish efficacy, according to the FDA.

The approval follows the December 2024 priority review designation for this perioperative immunotherapy regimen for patients fighting muscle-invasive bladder cancer.

Data from the ATLAS research comprises a series of trials that have yielded years of long-term, comprehensive data on the safety and efficacy of fitusiran (Qfitlia; Sanofi).

With strong progression-free survival benefits demonstrated in the CABINET trial and updates to National Comprehensive Cancer Network guidelines, this approval reinforces cabozantinib’s role in improving outcomes for patients facing these challenging cancers.

The approval of revakinagene taroretcel (Encelto; Neurotech) addresses a significant unmet need for patients with macular telangiectasia type 2 (MacTel), clinical investigator Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, said.

Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, discusses data supporting the FDA approval of revakinagene taroretcel-lwey (Encelto; Neurotech Pharmaceuticals), the first and only therapy indicated for the treatment of macular telangiectasia type 2 (MacTel).

Iptacopan's (Fabhalta; Novartis) approval makes it the first and only treatment approved for C3 glomerulopathy.

Despite resubmitting after an initial complete response letter (CRL) due to manufacturing issues, the combination therapy received a second CRL as a frontline therapy for unresectable hepatocellular carcinoma (HCC).

The FDA has approved guselkumab (Tremfya) as the first IL-23 inhibitor offering both subcutaneous and intravenous induction options for adults with moderate to severe active Crohn disease.

Christopher L. Moertel, MD, University of Minnesota, discusses the trial data that helped get mirdametinib approved and what providers can do to keep measuring quality of life (QOL) improvements.

Revakinagene taroretcel-lwey (Encelto; Neurotech), an allogeneic encapsulated cell-based gene therapy, is the first therapy to be approved for macular telangiectasia type 2.

Furosemide injection was previously approved to treat congestion from fluid buildup in adults with chronic heart failure.

The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for osteoporosis and bone loss in various patient populations.

Tislelizumab plus chemotherapy received FDA approval as a frontline therapy for individuals with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1.

Several rare disease patient populations received their first-ever FDA-approved drug since Rare Disease Day last year, signifying progress in closing treatment gaps for rare disease.

The FDA approves BrainSense Adaptive deep brain stimulation and electrode identifier technology for the treatment of Parkinson disease.

With 2 new self-administration methods, patients living with generalized myasthenia gravis can be more empowered to manage their treatment with greater independence and control.

Merilog (insulin-aspart-szjj) is the first rapid-acting insulin biosimilar to Novolog (insulin aspart) that is designated to improve glycemic control in adults and adolescents with type 2 diabetes.

The FDA approved Amneal Pharmaceuticals' generic lenalidomide capsules, referencing Celgene's Revlimid, in multiple strengths.

The FDA approved Ospomyv and Xbryk, denosumab biosimilars that could expand access to treatment for osteoporosis, cancer-related bone loss, and other endocrine diseases.