Rx Product News (October 2020)
This month's featured products include oliceridine, risdiplam, belantamab mafodotin-blmf, and tafasitamab-cxix .
OLICERIDINE (OLINVYK)MANUFACTURED BY: Trevena
The FDA recently approved the opioid oliceridine for intravenous (IV) use in the hospital setting, indicated for patients with severe pain who require an IV opioid when alternative treatments are inadequate. With a recommended daily dose limit of 27 mg, a clinical trial found that patients who received oliceridine reported a decrease in pain compared with patients who received a placebo. Oliceridine has a safety profile similar to other opioids. Common adverse effects include constipation, dizziness, headache, nausea, and vomiting, according to a company statement.
FOR MORE INFORMATION: trevena.com
RISDIPLAM (EVRYSDI)MANUFACTURED BY: Genentech and PTC Therapeutics
The FDA has approved Risdiplam for the treatment of spinal muscular atrophy (SMA) in adults and children aged 2 months and older. It is the first at-home, orally administered treatment for SMA in these populations, and it is designed to distribute evenly to all parts of the body, including the central nervous system. In 2 clinical trials, risdiplam showed clinically meaningful improvements in motor function and obtainment of developmental milestones in patients aged 2 months and older who presented vital functions and improved survival at 12 months. The most common adverse effects were diarrhea, fever, and rash in later-onset SMA and included constipation, pneumonia, upper-respiratory-tract infection, and vomiting in infantile-onset SMA.
FOR MORE INFORMATION: gene.com
BELANTAMAB MAFODOTIN-BLMFMANUFACTURED BY: GlaxoSmithKline
The FDA has granted accelerated approval to Belantamab Mafodotin-BLMF, a monotherapy treatment for adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, an immunomodulatory agent, and a proteasome inhibitor. The approval was based on 6-month primary results from a study that found a clinically meaningful overall response rate of 31% in patients who had received a median of 7 prior lines of treatment. The most common reported adverse effects included blurred vision, decreased visual acuity, fatigue, infusion-related reactions, keratopathy, nausea, and pyrexia.
FOR MORE INFORMATION: gsk.com
TAFASITAMAB-CXIX (MONJUVI)MANUFACTURED BY: Incyte and MorphoSys
Tafasitamab has been approved in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant. Precautions and warnings include infusion-related reactions; serious or severe myelosuppression, including neutropenia; and thrombocytopenia.
FOR MORE INFORMATION: morphosys.com