Product Approvals and Launches

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.

For multiple sclerosis, the therapy will be sold as Kesimpta by Novartis; it is administered by patients once a month through the Sensoready autoinjector pen.

Satralizumab is the third drug to be approved by the FDA for neuromyelitis optica spectrum disorder (NMOSD).

A new oral therapy approved by the FDA will provide patients with myelodysplastic syndromes, who typically visit a health care facility for intravenous treatment, with an oral at-home option that can be beneficial during the coronavirus pandemic.

The FDA today granted accelerated approval to the second biomarker-based indication for Merck’s pembrolizumab (Keytruda), an anti-PD-1 therapy, regardless of tumor type. A companion diagnostic to pembrolizumab, FoundationOne CDx was also today approved by the FDA as only approved companion diagnostic to measure tumor mutational burden.

The FDA approved Bristol Myers Squibb’s ozanimod (Zeposia) 0.92 mg as an oral treatment for relapsing forms of multiple sclerosis (RMS). Ozanimod can be used to treat clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.