September 2021 Rx Product News

EMPAGLIFLOZIN (JARDIANCE)

Marketed by Eli Lilly and Company

Breakthrough results confirmed that the EMPEROR-Preserved phase 3 trial (NCT03057951) of empagliflozin met its primary end point, establishing the drug as the first therapy to significantly reduce the risk of cardiovascular death or hospitalization for heart failure (HF) with preserved ejection fraction. When added to results from the EMPEROR-Reduced trial (NCT03057977), these findings demonstrate the efficacy of empagliflozin in all forms of HF and in patients both with and without diabetes, according to a statement from Eli Lilly and Company. Empagliflozin is not approved for the treatment of HF in the United States, though a supplemental new drug application has been submitted to the FDA. The indication would be to reduce the risk of cardiovascular death, heart failure, or hospitalization in adults with HF with reduced ejection fraction. A decision is expected later in 2021.

For more information: lilly.com

FINERENONE (KERENDIA)

Marketed by Bayer Healthcare

The FDA has approved finerenone to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), kidney failure, kidney function decline, and nonfatal heart attack in adults with chronic kidney disease associated with type 2 diabetes. Clinical trial results showed that the treatment led to a reduction in the risk of cardiovascular death, hospitalization for HF, and nonfatal heart attack among patients in the investigational arm. Adverse effects can include hyperkalemia, hyponatremia, and hypotension. Individuals with adrenal insufficiency and those receiving simultaneous treatment with strong CYP3A4 inhibitors should not receive finerenone.

For more information: bayer.com

UPADACITINIB (RINVOQ)

Marketed by AbbVie

Significantly more patients receiving upadacitinib achieved the primary end point of clinical remission in a 52-week phase 3 maintenance study of patients with moderate to severe ulcerative colitis. Upadacitinib is a reversible and selective Janus kinase inhibitor being investigated for the treatment of several immune-mediated inflammatory diseases. All secondary end points were also met, including the achievement of corticosteroid-free clinical remission at week 52, endoscopic improvement, and histologic-endoscopic mucosal improvement. No new safety risks were identified, and the most common adverse events observed in the upadacitinib groups were blood creatine phosphokinase increase, exacerbation of ulcerative colitis, and nasopharyngitis.

For more information: abbvie.com

TEZEPELUMAB

Marketed by Amgen Pharmaceuticals in collaboration with AstraZeneca

The FDA has granted priority review to tezepelumab for the management of asthma. The biologics license application from Amgen is based on results from the PATHFINDER clinical trial program, which includes results from the pivotal NAVIGATOR phase 3 trial. (NCT03347279). In this trial, tezepelumab demonstrated a clinically meaningful and statistically significant reduction in the annualized asthma exacerbation rate among this patient population. Investigators found no meaningful differences in safety results between the placebo and tezepelumab groups in the NAVIGATOR trial. A breakthrough therapy designation was granted to tezepelumab in 2018 for the treatment of patients with severe asthma without an eosinophilic phenotype.

For more information: amgen.com