Rx Product News (May 2020)

MANUFACTURED BY: Lundbeck

The FDA has approved the first and only intravenous preventive treatment for migraine, a clinically complex disease that can be accompanied by an array of symptoms. Eptinezumab-jjmr, a humanized monoclonal antibody, binds to calcitonin gene-related peptide ligand and blocks it from binding to the receptor. The drug’s efficacy was demonstrated in 2 phase 3 clinical trials, which found that the percentage of patients experiencing migraine was lower for those patients receiving the drug than those who got the placebo. The recommended dose is 100 mg every 3 months, though some patients may benefit from a 300-mg dose.

FOR MORE INFORMATION: lundbeckus.com

OSILODROSTAT (ISTURISA)MANUFACTURED BY: Novartis

The FDA has approved osilodrostat oral tablets for the treatment of adults with Cushing disease who either cannot undergo pituitary gland surgery or had surgery but still have the disease. The drug is taken orally twice a day as directed by a health care provider, who may reevaluate dosages, depending on the patient’s response. Of 137 adult participants in a 24-week study, about half achieved normal cortisol levels at the end of the study period. The most commonly reported adverse effects were adrenal insufficiency, edema, fatigue, headache, nausea, and vomiting.

FOR MORE INFORMATION: novartis.com

ISATUXIMAB-IRFC (SARCLISA)MANUFACTURED BY: Sanofi

The FDA has approved isatuximab-irfc, in combination with dexamethasone and pomalidomide, for the treatment of adults with multiple myeloma who received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor. The drug is a CD38-directed cytolytic antibody administered through intravenous infusion, which helps certain immune system cells attack cancerous cells. In clinical trials, common adverse effects included anemia, diarrhea, infusion-related reactions, neutropenia, pneumonia, and upper respiratory tract infection.

FOR MORE INFORMATION: sanofi.us

ADJUVANTED INFLUENZA VACCINE (FLUAD QUADRIVALENT)MANUFACTURED BY: Seqirus

Adults 65 years and older have a new seasonal flu vaccine, the first adjuvanted quadrivalent influenza vaccine for that age group. Older patients are at increased risk of influenza-related complications each season, and the company aims to protect this population with its new vaccine, according to a statement. Findings from a randomized trial at Brown University in Providence, Rhode Island, showed that, compared with standard influenza vaccines, the new vaccine significantly reduces

hospitalization risk for adults 65 years and older living in nursing homes.

FOR MORE INFORMATION: seqirus.com