Product Approvals and Launches

Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.

The FDA this week approved cabotegravir (Apretude), the first and only long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1.

Secukinumab is approved for use among patients with enthesitis-related arthritis (ERA) aged 4 years and up, and those with psoriatic arthritis (PsA) who are at least 2 years old.

Up to 500 million at-home COVID-19 test kits will be sent to US households for free, by request; Biogen cut the price of its Alzheimer disease drug Aduhelm nearly in half; the FDA approved the world’s first injectable medication to reduce the risk of sexually transmitted HIV.

The oral polymerization inhibitor, a first-in-class therapy for sickle cell disease, was first approved by the FDA for adults and pediatric patients 12 years of age and older in 2019.

The FDA approved FoundationOneCDx as the first companion diagnostic for current and future BRAF inhibitor therapeutics used to treat melanoma, including both monotherapies and combination therapies.

An FDA advisory panel voted in favor of emergency authorization for Merck's COVID-19 pill; South African drug maker Aspen Pharmacare announced that it was finalizing the first agreement to control production of the Johnson & Johnson COVID-19 vaccine in Africa; the International AIDS Society launched its latest strategy to find a cure for HIV.

The first-of-its-kind port delivery system with ranibizumab serves as the first wet age-related macular degeneration (AMD) treatment in 15 years to provide an alternative to frequent eye injections.

Sold under the name Dupixent, dupilumab is a biologic that inhibits interleukin (IL)-4 and IL-13, which are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis, and eosinophilic esophagitis.

The product, called Rethymic, is composed of human allogeneic thymus tissue that is processed and cultured and then implanted into children born without a thymus to help reconstitute immunity.

Maralixibat is the first treatment approved for cholestatic pruritus in patients with Alagille syndrome who are 1 year or older.

Ruxolitinib cream, to be sold under the name Opzelura, is the first topical Janus kinase inhibitor cream for the treatment of atopic dermatitis.

Chronic graft-vs-host disease (GVHD) is a condition that can occur after an allogeneic stem cell transplant in which the donated cells initiate an immune response and attack the transplant recipient’s organs.

Byooviz becomes the first FDA-approved ophthalmology biosimilar and the first FDA-approved biosimilar referencing Lucentis (ranibizumab), according to a statement from developers Samsung Bioepis and Biogen.

Patients with EGFR Exon20 insertion+ non–small cell lung cancer (NSCLC) make up approximately 1% to 2% of patients with NSCLC and have lacked treatment options.

This is the third approval for zanubrutinib, which is sold as Brukinsa by BeiGene.

The approval of zanubrutinib makes it just the second therapy indicated for this rare type of lymphoma.

Pfizer's COVID-19 vaccine has gained full approval from the FDA.

Jazz Pharmaceuticals’ Xywav oral solution is the first treatment to be approved for adults with idiopathic hypersomnia.

FDA approves avalglucosidase alfa-ngpt (Nexviazyme) for the treatment of patients 1 year and older with late-onset Pompe disease.

The designation means that pharmacists can switch patients to the less-expensive version of insulin without seeking approval from the clinician.

Positive drug trial results suggest promising outcomes for adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

The FDA issued a 510(k) clearance for the artificial intelligence software platform EnsoSleep, expanding its capabilities in assessing patients with chronic respiratory and cardiac conditions, as well as in pediatric populations ages 13 and above.

Last year, a data monitoring committee halted the DAPA-CKD trial when it found the evidence of efficacy was overwhelming, after it was shown the trial met all its primary and secondary end points for patients with chronic kidney disease, with and without type 2 diabetes.

Multiple myeloma is the second most common blood cancer, affecting more than 130,000 US patients.

The approval marks the first B-cell maturation antigen-directed genetically modified autologous chimeric antigen receptor T-cell therapy for patients with relapsed or refractory multiple myeloma.

The new indication for osimertinib (Tagrisso) marks the first FDA approval of an adjuvant treatment for non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations.

Voclosporin, the first FDA-approved oral therapy for lupus nephritis, will be sold as Lupkynis by Aurinia Pharmaceuticals and is approved for use in conjunction with immunosuppressive treatment.

The liquid serum assay was cleared for use as a companion diagnostic for olaparib to identify patients with BRCA1/2- and/or ATM-mutated metastatic castration-resistant prostate cancer.