Rx Product News (June 2020)

: Bristol Myers Squibb

The FDA recently approved luspatercept-aamt for the treatment of anemia that fails to respond to an erythropoiesis-stimulating agent and requires 2 or more red blood cell units over 8 weeks in adults with very low- to intermediate-risk myelodysplastic syndromes. This is the first and only erythroid maturation agent for this condition, according to a company statement. The approval was based on results from the phase 3 MEDALIST trial. Major adverse events reported in clinical trials included diarrhea, dizziness, dyspnea, fatigue, headaches, hypersensitivity reactions, musculoskeletal pain, and upper respiratory tract infection. The FDA first approved luspatercept-aamt for the treatment of anemia in adults with β-thalassemia who require regular red blood cell transfusions.

FOR MORE INFORMATION: reblozylpro.com

EPTINEZUMAB-JJMR (VYEPTI)MANUFACTURED BY: Lundbeck

Eptinezumab-jjmr, the first and only intravenous treatment for migraine prevention, is now commercially available in the United States. It can be obtained via select specialty distributors and specialty pharmacies. The FDA approved the drug in February 2020, after its safety and efficacy were demonstrated in 2 phase 3 clinical trials. In the trials, eptinezumab-jjmr met its primary end point of a decrease in mean monthly migraine days over months 1 to 3 in both chronic and episodic migraines. The most common adverse events were hypersensitivity and nasopharyngitis.

FOR MORE INFORMATION: vyeptihcp.com

COAGULATION FACTOR VIIA (RECOMBINANT)-JNCW (SEVENFACT)MANUFACTURED BY: LFB

The FDA recently approved coagulation factor VIIA (recombinant)-jncw for the control and treatment of bleeding episodes in adolescents ages 12 years and older with hemophilia A or B with inhibitors. The drug is the first to use a recombinant analog of human FVII expressed in the mammary gland of genetically engineered rabbits. Two studies found that the most common adverse events were dizziness, fever, headache, infusion-related reaction, and infusion site discomfort or hematoma.

FOR MORE INFORMATION: groupe-lfb.com/en

DURVALUMAB (IMFINZI)MANUFACTURED BY: AstraZeneca

The FDA has approved durvalumab as a new first-line treatment for patients with extensive-stage small cell lung cancer in combination with etoposide and either carboplatin or cisplatin. The drug is a human monoclonal antibody that binds to PD-L1 and counters the tumor’s immune-evading tactics. The phase 3 CASPIAN trial found a clinically meaningful and statistically significant improvement in overall survival among patients receiving durvalumab. The most common adverse events included alopecia, asthenia, fatigue, and nausea.

FOR MORE INFORMATION: imfinzi.com