Humira biosimilar to be launched by online pharmacy
Mark Cuban's Cost Plus Drugs, an online pharmacy that sells medications directly to consumers at lower prices, is expected to sell Yusimry, Coherus BioSciences' biosimilar of AbbVie's Humira. Cost Plus Drugs will sell Yusimry for $569.27 per carton plus dispensing and shipping fees, compared with the current list price of Humira at $6,922 per carton. Cuban's pharmacy plans to eventually carry other Humira biosimilars available on the US market.
Cost Plus Drugs seeks to lower drug prices by selling them at a fixed 15% markup plus pharmacy fees. Although Cost Plus Drugs accepts some insurance plans, the online pharmacy delivers the highest cost savings to people who are uninsured or underinsured.
FDA approves new class of medications for pediatric T2DM
The FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride), both products of Boehringer Ingelheim, as additions to diet and exercise to improve blood glucose control in children age 10 years and older with type 2 diabetes mellitus (T2DM). The approvals create a new class of oral medications for pediatric T2DM.
In a clinical trial of 157 children ages 10 to 17 with T2DM, treatment with Jardiance was superior in reducing hemoglobin A1C compared with placebo at 26 weeks; patients treated with Jardiance also had reductions in fasting plasma glucose compared with placebo.
The most common adverse reactions in children were generally similar to those in adults, except for the risk of hypoglycemia, which was higher among pediatric patients.
FDA approves first cellular therapy for T1DM
The FDA approved CellTrans' Lantidra (donislecel-jujn), the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of adults with type 1 diabetes mellitus (T1DM) who are unable to approach target hemoglobin A1C levels because of repeat episodes of severe hypoglycemia despite intensive management.
Lantidra is believed to work through the infused cells' secretion of insulin. It is administered as a single infusion into the hepatic portal vein; an additional infusion may be performed depending on the patient's response to the initial dose. The drug must be used with concomitant immunosuppression.
The safety and effectiveness of Lantidra were evaluated in two studies with a total of 30 participants with T1DM and hypoglycemic unawareness. Participants received a minimum of one and maximum of three infusions. Ultimately, 4 participants did not require insulin for less than 1 year, 12 participants for 1 to 5 years, and 9 participants for more than 5 years. Five participants did not achieve insulin independence for any amount of time.
The most common adverse reactions were nausea, fatigue, anemia, diarrhea, and abdominal pain. Most participants experienced at least one serious adverse reaction.
FDA fully approves new Alzheimer disease treatment
The FDA formally approved Leqembi (lecanemab-irmb) for adult patients with Alzheimer disease. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional FDA approval for the treatment of Alzheimer disease. The FDA recently determined that a phase 3 confirmatory study verified the drug's safety and efficacy.
The most common adverse reactions of Leqembi include headache, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA). Although ARIA usually resolve over time, a boxed warning is included in the prescribing information about serious and life-threatening risks associated with ARIA. The FDA recommends protein amyloid and genetic testing to assess safety risk.
Medicare announced it would cover 80% of the high annual cost ($26,500) of Leqembi; prescribing requirements include blood tests and entry in patient registries. Leqembi is a product of Eisai and Biogen.