Rx Product News: March 2021

Ioteprednol etabonate ophthalmic suspension 0.25% (Eysuvis)

Marketed by Kala Pharmaceuticals

The FDA has approved Eysuvis, making it the first ocular corticosteroid for the treatment of dry eye disease and the first prescription therapeutic to specifically address short-term needs of patients with dry eye disease. Dry eye disease is a chronic condition affecting the ocular surface and tears and can cause discomfort, ocular inflammation, tear film instability, and visual disturbance. The solution is indicated for up to 2 weeks of use in patients with dry eye disease based on the results of 4 clinical trials. Kala plans to launch Eysuvis in the United States by year-end.

For More Information: kalarx.com

Crizotinib (Xalkori)

Marketed by Pfizer Inc

Crizotinib is the first FDA-approved biomarker-driven therapy for relapsed/refractory anaplastic large cell lymphoma (ALCL) in children and young adults. The treatment is indicated for pediatric patients 1 year and older with ALK-positive relapsed/refractory ALCL. ALCL is a rare form of non-Hodgkin lymphoma (NHL) and accounts for approximately 30% of NHL cases in young people. Approximately 90% of pediatric patients and young adults with ALCL are ALK positive. The most common adverse reactions to the drug in clinical trials included decreased appetite, diarrhea, fatigue, headache, musculoskeletal pain, nausea, stomatitis, vision disorder, and vomiting.

For More Information: pfizer.com

Darolutamide (Nubeqa)

Marketed by Bayer

The FDA has approved a supplemental new drug application to add overall survival and other secondary end point data from the phase 3 ARAMIS trial to the prescribing information for darolutamide for the treatment of patients with nonmetastatic prostate cancer (nmCRPC). Darolutamide led to a 31% reduction in the risk of death, extending survival for patients with nmCRPC. The additional findings are time to pain progression and time to the initiation of cytotoxic chemotherapy, and the prescribing information also was updated to include further guidance on drug interactions. The final analysis of the trial reinforced the safety profile of darolutamide with an extended follow-up of median 29 months for the overall study population, according to a company press release.

For More Information: nubeqa-us.com

Anakinra (Kineret)

Marketed by Sobi

The FDA has expanded the indication for anakinra to include treatment of deficiency of IL-1 receptor antagonist (DIRA), an ultrarare, autoinflammatory disease. The FDA approved anakinra in November 2001 for treatment of moderate to severe active rheumatoid arthritis and in January 2013 for treatment of a severe form of cryopyrin-associated periodic syndromes. The efficacy and safety of anakinra for DIRA were evaluated in a long-term natural history study including 9 patients with genetically confirmed DIRA, aged 1 month to 9 years at the start of the study, who were treated with anakinra for up to 10 years. All 9 patients achieved inflammatory remission while on anakinra treatment.

For More Information: kineretrx.com